High Performance Liquid Chromatography:Article Title:
Article Snippet: .. Assay Principle Cation exchange high performance liquid Cation exchange high performance liquid chromatography chromatography Sample Type Human anticoagulated whole blood (EDTA) Human anticoagulated whole blood (EDTA) Visible Detection 415 not 415 mn Results Variant windows for S, C and any additional Variant windows for S, C, D and any additional unknown peaks will be detected as "unknown" unknown peaks will be detected as "unknown" Normal Reference Compared to "normal" pattern of Compared to "normal" pattern of Interval chromatography chromatography Time to process 6.5 minutes 6.5 minutes sample Bio-Rad D-10 Dual Program Page E-7 rev Date Revised: 05/28/04 Testing To Establish Substantial Equivalence: Accuracy: HbA,, Method correlation between Bio-Rad D-10TM Dual Program (6.5 minutes) and VARIANT TM II Hemoglobin A,, Program was evaluated using 40 EDTA whole blood samples ranging from 4.7% to 1 1.2% HbAj,. .. The results are presented in the following table: D-1 0 TM Dual Program (6.5 Minutes) Correlation for HbAj, Regression Method n r2 Interce t Least Squares 40 0.9843 0.9906 0.4310 HbA 2 Method correlation between Bio-Rad D-10TM Dual Program (6.5 minutes) and VARIANT' TM II/ - thalassemia Short Program was evaluated with 40 EDTA whole blood samples ranging from 1.9% to 8.9% HbA2.
Article Title:
Article Snippet: .. Similarities Item Device Predicate Intended Use The Bio-Rad D-10TM Dual Program is intended for the percent determination of hemoglobin A1c, A2, and F, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC). .. The Bio-Rad D-10TM Dual Program is intended for Professional Use only.
Article Title: Peripheral Blood Film Patterns in Thalassemia and Hemoglobinopathy Carrier
Article Snippet: .. HPLC were done by BIO-RAD D-10TM Dual program for determination of different fractions of hemoglobin level. ..
Article Title:
Article Snippet: .. Technical Characteristics Compared to Predicate The Bio-Rad D-10TM Dual Program [identified herein as the: "D-10OTM Dual" or "D-1OTM Dual Program [6.5 minute)" system] and its 2 cleared predicates, the VARIANTTM II Hemoglobin A,, (K984268) and VARIANT T M II i-thalassemia (K991127) Programs, have the same technical HPLC and general program characteristics that are summarized in the following tables: Bio-Rad D-10 Dual Program Page E-3 rev Date Revised: 05/28/04 HbAl, Characteristics Bio-Rad D-1 0TM Dual Program VARIANT II Hemoglobin Al, Program (6.5 Minutes) [Cleared: / K984268; 12/17/981 Intended Use(s) The Bio-Rad D-10 Dual Program system is The VARIANT II Hemoglobin A,, Program is intended for the percent determination of intended for the determination of hemoglobin hemoglobins A,,, A2 and F, and for the At, in human whole blood using ion-exchange detection of abnormal hemoglobins in human high performance liquid chromatography whole blood using ion-exchange high (HPLC) performance liquid chromatography (HPLC). .. The VARIANT II Hemoglobin A,, Program is The Bio-Rad D-10 Dual Program is intended intended for use only with the Bio-Rad for in Professional Use only.
Article Title:
Article Snippet: Special instrument Requirements: Bio-Rad D-10TM Hemoglobin Testing System .. The Bio-Rad D-10TM Dual Program is a testing system that uses HPLC for the chromatographic separation of Hemoglobins A1c, A2, F and related hemoglobins that may be present in human blood. ..
Article Title:
Article Snippet: .. Intended use(s): The Bio-Rad D-10TM Dual Program is intended for the percent determination of hemoglobin A1c, A2 and F, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC). ..
Chromatography:Article Title:
Article Snippet: .. Assay Principle Cation exchange high performance liquid Cation exchange high performance liquid chromatography chromatography Sample Type Human anticoagulated whole blood (EDTA) Human anticoagulated whole blood (EDTA) Visible Detection 415 not 415 mn Results Variant windows for S, C and any additional Variant windows for S, C, D and any additional unknown peaks will be detected as "unknown" unknown peaks will be detected as "unknown" Normal Reference Compared to "normal" pattern of Compared to "normal" pattern of Interval chromatography chromatography Time to process 6.5 minutes 6.5 minutes sample Bio-Rad D-10 Dual Program Page E-7 rev Date Revised: 05/28/04 Testing To Establish Substantial Equivalence: Accuracy: HbA,, Method correlation between Bio-Rad D-10TM Dual Program (6.5 minutes) and VARIANT TM II Hemoglobin A,, Program was evaluated using 40 EDTA whole blood samples ranging from 4.7% to 1 1.2% HbAj,. .. The results are presented in the following table: D-1 0 TM Dual Program (6.5 Minutes) Correlation for HbAj, Regression Method n r2 Interce t Least Squares 40 0.9843 0.9906 0.4310 HbA 2 Method correlation between Bio-Rad D-10TM Dual Program (6.5 minutes) and VARIANT' TM II/ - thalassemia Short Program was evaluated with 40 EDTA whole blood samples ranging from 1.9% to 8.9% HbA2.
Variant Assay:Article Title:
Article Snippet: .. Assay Principle Cation exchange high performance liquid Cation exchange high performance liquid chromatography chromatography Sample Type Human anticoagulated whole blood (EDTA) Human anticoagulated whole blood (EDTA) Visible Detection 415 not 415 mn Results Variant windows for S, C and any additional Variant windows for S, C, D and any additional unknown peaks will be detected as "unknown" unknown peaks will be detected as "unknown" Normal Reference Compared to "normal" pattern of Compared to "normal" pattern of Interval chromatography chromatography Time to process 6.5 minutes 6.5 minutes sample Bio-Rad D-10 Dual Program Page E-7 rev Date Revised: 05/28/04 Testing To Establish Substantial Equivalence: Accuracy: HbA,, Method correlation between Bio-Rad D-10TM Dual Program (6.5 minutes) and VARIANT TM II Hemoglobin A,, Program was evaluated using 40 EDTA whole blood samples ranging from 4.7% to 1 1.2% HbAj,. .. The results are presented in the following table: D-1 0 TM Dual Program (6.5 Minutes) Correlation for HbAj, Regression Method n r2 Interce t Least Squares 40 0.9843 0.9906 0.4310 HbA 2 Method correlation between Bio-Rad D-10TM Dual Program (6.5 minutes) and VARIANT' TM II/ - thalassemia Short Program was evaluated with 40 EDTA whole blood samples ranging from 1.9% to 8.9% HbA2.
Article Title:
Article Snippet: .. Technical Characteristics Compared to Predicate The Bio-Rad D-10TM Dual Program [identified herein as the: "D-10OTM Dual" or "D-1OTM Dual Program [6.5 minute)" system] and its 2 cleared predicates, the VARIANTTM II Hemoglobin A,, (K984268) and VARIANT T M II i-thalassemia (K991127) Programs, have the same technical HPLC and general program characteristics that are summarized in the following tables: Bio-Rad D-10 Dual Program Page E-3 rev Date Revised: 05/28/04 HbAl, Characteristics Bio-Rad D-1 0TM Dual Program VARIANT II Hemoglobin Al, Program (6.5 Minutes) [Cleared: / K984268; 12/17/981 Intended Use(s) The Bio-Rad D-10 Dual Program system is The VARIANT II Hemoglobin A,, Program is intended for the percent determination of intended for the determination of hemoglobin hemoglobins A,,, A2 and F, and for the At, in human whole blood using ion-exchange detection of abnormal hemoglobins in human high performance liquid chromatography whole blood using ion-exchange high (HPLC) performance liquid chromatography (HPLC). .. The VARIANT II Hemoglobin A,, Program is The Bio-Rad D-10 Dual Program is intended intended for use only with the Bio-Rad for in Professional Use only.
Liquid Chromatography:Article Title:
Article Snippet: .. Technical Characteristics Compared to Predicate The Bio-Rad D-10TM Dual Program [identified herein as the: "D-10OTM Dual" or "D-1OTM Dual Program [6.5 minute)" system] and its 2 cleared predicates, the VARIANTTM II Hemoglobin A,, (K984268) and VARIANT T M II i-thalassemia (K991127) Programs, have the same technical HPLC and general program characteristics that are summarized in the following tables: Bio-Rad D-10 Dual Program Page E-3 rev Date Revised: 05/28/04 HbAl, Characteristics Bio-Rad D-1 0TM Dual Program VARIANT II Hemoglobin Al, Program (6.5 Minutes) [Cleared: / K984268; 12/17/981 Intended Use(s) The Bio-Rad D-10 Dual Program system is The VARIANT II Hemoglobin A,, Program is intended for the percent determination of intended for the determination of hemoglobin hemoglobins A,,, A2 and F, and for the At, in human whole blood using ion-exchange detection of abnormal hemoglobins in human high performance liquid chromatography whole blood using ion-exchange high (HPLC) performance liquid chromatography (HPLC). .. The VARIANT II Hemoglobin A,, Program is The Bio-Rad D-10 Dual Program is intended intended for use only with the Bio-Rad for in Professional Use only.
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