(8 days)
The Bio-Rad D-10™ Dual Program system is intended for the percent determination of hemoglobins A1c, A2, and F and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC). Measurement of the percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus, and measurement of the percent HbA2 and HbF is effective in long-term monitoring of ß—thalassemias (i.e., hereditary hemolytic anemias characterized by decreased synthesis of one or more types of abnormal hemoglobin polypeptide chains). Detection of hemoglobin thalassemia variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants. The Bio-Rad D-10TM Dual Program is intended for Professional Use Only. For in vitro diagnostics use.
The Bio-Rad D-10™ Dual Program is a new device system that utilizes the principles of high performance liquid chromatography (HPLC), by which chromatographic separation of performance nquild chromatography (THLC), of willen exchange cartridge. The Bio-Rad D-10™ nemogrooms is a new program system that combines the determination of percent hemoglobin A = 1 = d for diabetes monitoring with percent hemoglobins A2 and F used for evaluation of (3 = thalassemia. The D-10™ Dual Program system consists of two different reagent programs with two intended uses. The D-10TM Dual Program reagent kit has a short program (3 minutes) for the determination of hemoglobin Are in which the components exactly the same as the D-10™ Hemoglobin Atc Program (K031043) reagents. The second program includes an extended program (6.5 minutes) that can be used for the determination of HbA2, HbF as well as HbA1c The components are exactly the same as the D-10™ Hemoglobin A12 Program (K031043) system and reagents with an additional HbA2/F/A1e Calibrator/Diluent Set and floppy diskette for the new program parameters.
Here's a breakdown of the acceptance criteria and study information for the Bio-Rad D-10™ Dual Program, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Bio-Rad D-10™ Dual Program are not explicitly stated as distinct pass/fail thresholds in the document. Instead, the study aims to demonstrate substantial equivalence to existing predicate devices (VARIANT™ II Hemoglobin A1c Program and VARIANT™ II β-thalassemia Short Program). The performance of the D-10™ Dual Program is compared against these predicates across several metrics.
Table of Acceptance Criteria (Inferred by comparison to predicate) and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied: Comparable to Predicate) | Bio-Rad D-10™ Dual Program Reported Performance (6.5 Minutes) |
|---|---|---|
| HbA1c Accuracy | r² ≥ ~0.98, Slope ~1, Intercept ~0 | r² = 0.9843, Slope = 0.9906, Intercept = 0.4310 |
| HbA2 Accuracy | r² ≥ ~0.98, Slope ~1, Intercept ~0 | r² = 0.9832, Slope = 1.0898, Intercept = -0.2407 |
| HbF Accuracy | r² ≥ ~0.99, Slope ~1, Intercept ~0 | r² = 0.9959, Slope = 0.9497, Intercept = -0.1785 |
| HbA1c Precision (Normal Sample) | Total Precision (%CV) comparable to predicate (~2.1%) | Total Precision (%CV) = 1.8% |
| HbA1c Precision (Diabetic Sample) | Total Precision (%CV) comparable to predicate (~1.7%) | Total Precision (%CV) = 0.9% |
| HbA2 Precision (Low Sample) | Total Precision (%CV) comparable to predicate (~2.0%) | Total Precision (%CV) = 5.3% |
| HbA2 Precision (High Sample) | Total Precision (%CV) comparable to predicate (~2.1%) | Total Precision (%CV) = 3.1% |
| HbF Precision (Low Sample) | Total Precision (%CV) comparable to predicate (~3.9%) | Total Precision (%CV) = 3.3% |
| HbF Precision (High Sample) | Total Precision (%CV) comparable to predicate (~1.4%) | Total Precision (%CV) = 2.0% |
| HbA1c Linearity | % Recovery for theoretical vs. observed HbA1c comparable to predicate (e.g., 97-100%) | % Recovery for HbA1c is "essentially the same" (example: 97.7-100%) |
| HbA2 Linearity | % Recovery for theoretical vs. observed HbA2 comparable to predicate (e.g., 91-100%) | % Recovery for HbA2 is "essentially the same" (example: 91.2-100%) |
| HbF Linearity | % Recovery for theoretical vs. observed HbF comparable to predicate (e.g., 89-110%) | % Recovery for HbF is "essentially the same" (example: 100-112.5%) |
| Interference (Labile Hb on HbA1c) | No significant interference up to predicate levels (4.8%) | No significant interference up to 3.5% |
| Interference (Labile Hb on HbF) | No significant interference up to predicate levels (Not Applicable) | No significant interference up to 2.6% |
| Interference (Bilirubin) | No interference up to 20 mg/dL | No interference up to 20 mg/dL |
| Interference (Lipids) | No interference up to ~4600-6000 mg/dL | No interference up to 5680 mg/dL |
| Interference (EDTA) | No interference up to 11x EDTA | No interference up to 11x EDTA |
Study Details for Demonstrating Equivalence:
The study described is a series of laboratory performance evaluations comparing the Bio-Rad D-10™ Dual Program (6.5 minute extended program) to its predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- HbA1c Accuracy: 40 EDTA whole blood samples.
- HbA2 Accuracy: 40 EDTA whole blood samples.
- HbF Accuracy: 40 EDTA whole blood samples.
- HbA1c Precision: 80 measurements for each of two sample types (normal, diabetic) for both the D-10 Dual and VARIANT II HbA1c programs (total 320 measurements). Samples were EDTA whole blood patient samples.
- HbA2 Precision: 80 measurements for each of two sample types (low, high) for both the D-10 Dual and VARIANT II β-thalassemia Short programs (total 320 measurements). Samples were EDTA whole blood patient samples.
- HbF Precision: 80 measurements for each of two sample types (low, high) for both the D-10 Dual and VARIANT II β-thalassemia Short programs (total 320 measurements). Samples were EDTA whole blood patient samples.
- Linearity (HbA1c, HbA2, HbF): Eight EDTA-based blood standards (n=2 for each standard) were used for comparison. The document also mentions a "first linearity study" using seven standards (n=2 for each).
- Specificity and Interference: Varies by substance.
- Carbamylated hemoglobin: Specimens spiked with sodium cyanate.
- Labile hemoglobin: Samples spiked with glucose.
- Bilirubin, Lipids, EDTA: Patient pools or individual blood samples obtained as EDTA-anticoagulated blood, with concentrated interfering substances added.
Data Provenance: The document does not explicitly state the country of origin. It indicates that samples were "human whole blood samples" or "human anticoagulated whole blood (EDTA)," and "patient bloods." The context of a 510(k) submission to the FDA for a device manufactured by Bio-Rad Laboratories (Hercules, California) suggests the studies would likely be conducted in the United States or under similar regulatory standards. The studies appear to be retrospective in the sense that they are conducted on collected samples to evaluate the device performance against established methods, rather than following patients prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an imaging device requiring expert interpretation for ground truth. Ground truth for chemical assays is typically established by reference methods or validated (predicate) assays, or by preparing samples with known concentrations. The predicate devices serve this role.
4. Adjudication Method for the Test Set:
Not applicable for this type of quantitative assay comparison. The comparison is statistical (regression, percentage recovery, CV) against reference methods or predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this is not an MRMC study. This device is an automated in vitro diagnostic (IVD) device for biochemical analysis, not an imaging device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance data presented is for the Bio-Rad D-10™ Dual Program as a standalone device, reporting quantitative values of HbA1c, HbA2, and HbF. The comparison is directly between the new device and the predicate laboratory instruments.
7. The Type of Ground Truth Used:
For accuracy and precision, the "ground truth" for the D-10™ Dual Program is established through method correlation with predicate devices (VARIANT™ II Hemoglobin A1c Program and VARIANT™ II β-thalassemia Short Program). For linearity, "ground truth" refers to the theoretical concentrations of HbA1c, HbA2, and HbF in the prepared standards. For specificity/interference, ground truth involves known concentrations of interfering substances added to samples. The predicates themselves are established and cleared devices, implying their results are considered accurate and reliable. The HbA1c predicate is also traceable to the DCCT reference method and IFCC, and certified by NGSP.
8. The Sample Size for the Training Set:
The document describes performance studies for the new device as compared to predicate devices. It does not explicitly mention a "training set" in the context of machine learning, as this device relies on HPLC principles and established chemical analysis methods, not an AI/ML algorithm that would undergo specific training.
9. How the Ground Truth for the Training Set was Established:
As above, the concept of a "training set" and associated ground truth establishment is not directly applicable in the context of this traditional IVD device and its submission. The studies involve validation against predicate methods and known standards.
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K0414444
JUN - 9 2004
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K______________________________________________________________________________________________________________________________________________
| Submitter: | Bio-Rad LaboratoriesDiagnostics Group4000 Alfred Nobel Drive,Hercules, California 94547Phone: (510) 741-5309FAX: (510) 741-6471 |
|---|---|
| Contact Person: | Jackie BuckleyRegulatory Affairs Representative |
| Date of Summary Preparation: | April 16, 2004 |
| Device Name: | Bio-Rad D-10™ Dual Program |
| Classification Name: | HbA₁c: Assay, Glycosylated Hemoglobin[21CFR 864.7470 / Prod. Code LCP] andHbA₂: Hemoglobin A₂ Quantitation[21CFR 864.7400 / Prod. Code: JPD] |
| Predicate Devices: | HbA₁c: VARIANT™ II Hemoglobin A₁c ProgramBio-Rad Laboratories[K984268; 12/17/98] |
| HbA₂/F: VARIANT™ II β-thalassemia Short ProgramBio-Rad Laboratories[K991127; 06/10/99] | |
| Presumptive Hemoglobin Identification:VARIANT™ II β-thalassemia Short ProgramBio-Rad Laboratories[K991127; 06/10/99] | |
| Special Instrument Requirement:Bio-Rad D-10™ Hemoglobin Testing System[K031043; 08/27/03] |
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Image /page/1/Figure/0 description: The image is a predicate map for the D-10 Dual Program. It shows two assays, one for 3 minutes (short) and one for 6.5 minutes (extended). The 3-minute assay analyzes HbA1c, while the 6.5-minute assay analyzes HbF, HbA2, and HbA1c. The predicate methods are Variant II B-Thal Short (K991127), Variant II B-Thal Short (K991127), and Variant II Hemoglobin A1c (K984268), which is the same as D-10 Hemoglobin A1c (K031043).
Indications for Use Statement and Intended Uses:
The Bio-Rad D-10TM Dual Program system is intended for the percent determination of hemoglobins A1c, A2 and F, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC).
Measurement of the percent hemoglobin Aie is effective in monitoring long-term glucose control in individuals with diabetes mellitus, and measurement of the percent HbA 2and HbF are effective in long-term monitoring of ß-thalassemias (i.e., hereditary hemolytic anemias characterized by decreased synthesis of one or more types of abnormal hemoglobin polypeptide chains).
Detection of hemoglobin thalassemia variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants. The Bio-Rad D-10TM Dual Program is intended for Professional Use Only. For in vitro diagnostic use.
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Description of Device
The Bio-Rad D-10™ Dual Program is a new device system that utilizes the principles of high performance liquid chromatography (HPLC), by which chromatographic separation of performance nquild chromatography (THLC), of willen exchange cartridge. The Bio-Rad D-10™ nemogrooms is a new program system that combines the determination of percent hemoglobin A = 1 = d for diabetes monitoring with percent hemoglobins A2 and F used for evaluation of (3 = thalassemia. The D-10™ Dual Program system consists of two different reagent programs with two intended uses. The D-10TM Dual Program reagent kit has a short program (3 minutes) for the determination of hemoglobin Are in which the components exactly the same as the D-10™ Hemoglobin Atc Program (K031043) reagents. The second program includes an extended program (6.5 minutes) that can be used for the determination of HbA2, HbF as well as HbA1c The components are exactly the same as the D-10™ Hemoglobin A12 Program (K031043) system and reagents with an additional HbA2/F/A1e Calibrator/Diluent Set and floppy diskette for the new program parameters.
Technical Characteristics Compared to Predicate
The Bio-Rad D-10™ Dual Program [identified herein as the: "D-10″ Dual" or "D-10™ Dual Program [6.5 minute)" system] and its 2 cleared predicates, the VARIANT™ II Hemoglobin A (K984268) and VARIANT™ II B-thalassemia (K991127) Programs, have the same technical HPLC and general program characteristics that are summarized in the following tables:
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HbA1c
| Characteristics | Bio-Rad D-10™ Dual Program(6.5 Minutes) | VARIANT II Hemoglobin A1c Program[Cleared: / K984268; 12/17/98] |
|---|---|---|
| Intended Use(s) | The Bio-Rad D-10 Dual Program system isintended for the percent determination ofhemoglobins A1c, A2 and F, and for thedetection of abnormal hemoglobins in humanwhole blood using ion-exchange highperformance liquid chromatography (HPLC).The Bio-Rad D-10 Dual Program is intendedfor in Professional Use only. For in vitrodiagnostic Use. | The VARIANT II Hemoglobin A1c Program isintended for the determination of hemoglobinA1c in human whole blood using ion-exchangehigh performance liquid chromatography(HPLC).The VARIANT II Hemoglobin A1c Program isintended for use only with the Bio-RadVARIANT II Hemoglobin Testing System.For in vitro diagnostic use. |
| Indication(s) for Use | Measurement of the percent hemoglobin A1c iseffective in monitoring long-term glucosecontrol in individuals with diabetes mellitus,and measurement of the percent HbA2 and HbFare effective in monitoring of β-thalassemia(i.e., hereditary hemolytic anemiascharacterized by decreased synthesis of one ormore types of abnormal hemoglobinpolypeptide chains).Detection of hemoglobin thalassemia variantssuch as hemoglobins S, C, D and E by HPLC iseffective in presumptive identification of thesevariants. | Measurement of the percent hemoglobin A1c iseffective in monitoring long-term glucose controlin individuals with diabetes mellitus. |
| Assay Principle | Cation exchange high performance liquidchromatography | Cation exchange high performance liquidchromatography |
| Sample Type | Human anticoagulated whole blood (EDTA) | Human anticoagulated whole blood (EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Standardization | Traceable to the Diabetes Control andComplications Trial (DCCT) reference methodand IFCC. Certified via the NationalGlycohemoglobin Standardization Program(NGSP) for HbA1c. | Traceable to the Diabetes Control andComplications Trial (DCCT) reference methodand IFCC. Certified via the NationalGlycohemoglobin Standardization Program(NGSP) for HbA1c. |
| Results | Quantitative Area % HbA1c | Quantitative Area % HbA1c |
| Time to processsample | 6.5 minutes | 3.0 minutes |
| Expected ValueRange | 4.27 – 6.07 % HbA1c | 4.27 – 6.07 % HbA1c |
| Linearity | 3.7 – 18.4 % HbA1c | 1.3 – 18.9% HbA1c |
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HbA2
| Characteristics | Bio-Rad D-10TM Dual Program(6.5 Minutes) | VARIANT II β-thalassemia Short[Cleared: / K991127; 06/10/1999] |
|---|---|---|
| Intended Uses | The Bio-Rad D-10 Dual Program system isintended for the percent determination ofhemoglobins A1c, A2 and F, and for thedetection of abnormal hemoglobins in humanwhole blood using ion-exchange highperformance liquid chromatography (HPLC).The Bio-Rad D-10 Dual Program is intendedfor Professional Use Only. For in vitrodiagnostic use. | The VARIANT II β-thalassemia Short Programis intended for the separation and area percentdeterminations of hemoglobins A2 and F, andas an aid in the identification of abnormalhemoglobins in whole blood using ion-exchange high performance liquidchromatography.The VARIANT II β-thalassemia Short Programis intended for use only with the Bio-RadVARIANT II Hemoglobin Testing System.For in vitro diagnostic use. |
| Indication(s) for Use | Measurement of the percent hemoglobin A1c iseffective in monitoring long-term glucosecontrol in individuals with diabetes mellitus,and measurement of the percent HbA2 andHbF are effective in monitoring of β-thalassemia (i.e., hereditary hemolytic anemiascharacterized by decreased synthesis of one ormore types of abnormal hemoglobinpolypeptide chains).Detection of hemoglobin thalassemia variantssuch as hemoglobins S, C, D and E by HPLCis effective in presumptive identification ofthese variants. | Measurement of the percent HbA2 and HbF areeffective in monitoring of β-thalassemia (i.e.,hereditary hemolytic anemias characterized bydecreased synthesis of one or more types ofabnormal hemoglobin polypeptide chains).Identification of hemoglobin thalassemiavariants such as hemoglobins S, C, D and E byHPLC is effective in presumptive identificationof these variants. |
| Assay Principle | Cation exchange high performance liquidchromatography | Cation exchange high performance liquidchromatography |
| Sample Type | Human anticoagulated whole blood (EDTA) | Human anticoagulated whole blood (EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Standardization | The Joint Committee on Traceability inLaboratory Medicine has not identified ahigher order reference method or referencematerial for the quantitation of HbA2 and HbF | The Joint Committee on Traceability inLaboratory Medicine has not identified a higherorder reference method or reference material forthe quantitation of HbA2 and HbF |
| Results | Quantitative Area % HbA2 | Quantitative Area % HbA2 |
| Time to processsample | 6.5 minutes | 6.5 minutes |
| Expected ValueRange | 2.2 - 3.7 % HbA2 | 2.3 - 3.3% HbA2 |
| Linearity | 1.5 - 11.4 % HbA2 | 1.6 - 18.7% HbA2 |
| Characteristics | Bio-Rad D-10TM Dual Program(6.5 Minutes) | VARIANTTM II β-thalassemia Short[Cleared: / K991127; 06/10/1999] |
| Intended Uses | The Bio-Rad D-10 Dual Program system isintended for the percent determination ofhemoglobins A1c, A2 and F, and for thedetection of abnormal hemoglobins in humanwhole blood using ion-exchange highperformance liquid chromatography (HPLC).The Bio-Rad D-10 Dual Program is intendedfor Professional Use Only. For in vitrodiagnostic use. | The VARIANT II β-thalassemia Short Programis intended for the separation and area percentdeterminations of hemoglobins A2 and F, andas an aid in the identification of abnormalhemoglobins in whole blood using ion-exchange high performance liquidchromatography.The VARIANT II β-thalassemia Short Programis intended for use only with the Bio-RadVARIANT II Hemoglobin Testing System.For in vitro diagnostic use. |
| Indication(s) for Use | Measurement of the percent hemoglobin A1c iseffective in monitoring long-term glucosecontrol in individuals with diabetes mellitus,and measurement of the percent HbA2 andHbF are effective in monitoring of β-thalassemia (i.e., hereditary hemolytic anemiascharacterized by decreased synthesis of one ormore types of abnormal hemoglobinpolypeptide chains).Detection of hemoglobin thalassemia variantssuch as hemoglobins S, C, D and E by HPLCis effective in presumptive identification ofthese variants. | Measurement of the percent HbA2 and HbF areeffective in monitoring of β-thalassemia (i.e.,hereditary hemolytic anemias characterized bydecreased synthesis of one or more types ofabnormal hemoglobin polypeptide chains).Identification of hemoglobin thalassemiavariants such as hemoglobins S, C, D and E byHPLC is effective in presumptive identificationof these variants. |
| Assay Principle | Cation exchange high performance liquidchromatography | Cation exchange high performance liquidchromatography |
| Sample Type | Human anticoagulated whole blood (EDTA) | Human anticoagulated whole blood (EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Standardization | The Joint Committee on Traceability inLaboratory Medicine has not identified ahigher order reference method or referencematerial for the quantitation of HbA2 and HbF | The Joint Committee on Traceability inLaboratory Medicine has not identified a higherorder reference method or reference material forthe quantitation of HbA2 and HbF |
| Results | Quantitative Area % HbF | Quantitative Area % HbF |
| Time to processsample | 6.5 minutes | 6.5 minutes |
| Expected ValueRange | 0 - 0.8% HbF | <1.0% HbF |
| Linearity | 0.8 – 16.5 % HbF | 1.3 – 44.3% HbF |
| Characteristics | Bio-Rad D-10TM Dual Program(6.5 Minutes) | VARIANT II β-thalassemia Short [Cleared: /K991127; 06/10/1999] |
| Intended Uses | The Bio-Rad D-10 Dual Program system isintended for the percent determination ofhemoglobins A1c, A2 and F, and for thedetection of abnormal hemoglobins in humanwhole blood using ion-exchange highperformance liquid chromatography (HPLC).The Bio-Rad D-10 Dual Program is intendedfor Professional Use Only. For in vitrodiagnostic use. | The VARIANT II β-thalassemia Short Programis intended for the separation and area percentdeterminations of hemoglobins A2 and F, andas an aid in the identification of abnormalhemoglobins in whole blood using ion-exchange high performance liquidchromatography.The VARIANT II β-thalassemia Short Programis intended for use only with the Bio-RadVARIANT II Hemoglobin Testing System.For in vitro diagnostic use. |
| Indication(s) for Use | Measurement of the percent hemoglobin A1c iseffective in monitoring long-term glucosecontrol in individuals with diabetes mellitus,and measurement of the percent HbA2 andHbF are effective in monitoring of β-thalassemia (i.e., hereditary hemolytic anemiascharacterized by decreased synthesis of one ormore types of abnormal hemoglobinpolypeptide chains).Detection of hemoglobin thalassemia variantssuch as hemoglobins S, C, D and E by HPLCis effective in presumptive identification ofthese variants. | Measurement of the percent HbA2 and HbF areeffective in monitoring of β-thalassemia (i.e.,hereditary hemolytic anemias characterized bydecreased synthesis of one or more types ofabnormal hemoglobin polypeptide chains).Identification of hemoglobin thalassemiavariants such as hemoglobins S, C, D and E byHPLC is effective in presumptive identificationof these variants. |
| Assay Principle | Cation exchange high performance liquidchromatography | Cation exchange high performance liquidchromatography |
| Sample Type | Human anticoagulated whole blood (EDTA) | Human anticoagulated whole blood (EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Results | Variant windows for S, C and any additionalunknown peaks will be detected as "unknown" | Variant windows for S, C, D and any additionalunknown peaks will be detected as "unknown" |
| Normal ReferenceInterval | Compared to "normal" pattern ofchromatography | Compared to "normal" pattern ofchromatography |
| Time to processsample | 6.5 minutes | 6.5 minutes |
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HbF
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Hemoglobin Variants
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Testing To Establish Substantial Equivalence:
Accuracy:
HbAıc
Method correlation between Bio-Rad D-10™ Dual Program (6.5 minutes) and VARIANT™ II Hemoglobin At Program was evaluated using 40 EDTA whole blood samples ranging from 4.7% to 11.2% HbA1. The results are presented in the following table:
| ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | THESE T FORT SET ( Dir TATTERS ( COLL CRECCRON FOR BERT FL | |||
|---|---|---|---|---|
| Regression Method | Slope | Intercept | ||
| Least Squares | 40 | 0.9843 | 0.9906 | 0.4310 |
D. 10TM Dual Program (6.5 Minutes) Correlation for HbA.
HbAz
Method correlation between Bio-Rad D-10TM Dual Program (6.5 minutes) and VARIANT™ II 8thalassemia Short Program was evaluated with 40 EDTA whole blood samples ranging from 1.9% to 8.9% HbA2. The results are presented in the following table:
| D-10™ Dual Program (6.5 Minutes) Correlation for HbA₂ | ||||
|---|---|---|---|---|
| Regression Method | n | r² | Slope | Intercept |
| Least Squares | 40 | 0.9832 | 1.0898 | -0.2407 |
TM Duel Program (6.5 Minutes) Correlation for HbA
HbF
Method correlation between Bio-Rad D-10'™ Dual Program (6.5 minutes) and VARIANT™ II ß-thalassemia Short Program was evaluated with 40 EDTA whole blood samples ranging from 0% to 12.91% HbF. The results are presented in the following table:
| Regression Method | n | r2 | Slope | Intercept |
|---|---|---|---|---|
| Least Squares | 40 | 0.9959 | 0.9497 | -0.1785 |
D-10TM Dual Program (6,5 Minutes) Correlation for HbF
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Precision:
HbAjc
The following precision table provides comparison data on the precision between D-101™ Dual Program (6.5 Minutes) and VARIANT™ II Hemoglobin Air Program, each utilizing EDTA I rogum (0.5 Minites) and both tested against samples with normal (5.4-5.9) and diabetic (13.1-13.7) % Alc content.
Method precision was performed using a protocol based on the NCCLS Evaluation protocol, Vol.12, No. 4, EP5-A (Feb. 1999) for the D-10TM Dual Program (6.5 Minutes) and NCCLS Fealuation protocol, Vol.12, No. 4, EP5-T2 (Mar. 1992) for the VARIANT II Hemoglobin Are Program. The protocols for both the D-10TM Dual Program (6.5 Minutes) and VARIANT II Hemoglobin Aic Programs are similar. Using these protocols, 40 runs (2 per day) were remoglobin 1 ( 1 1 0 g 1 1 1 (or V ARIANT ™ II) Hemoglobin Testing System over 20 working days. In each duplicate daily run, duplicate aliquots of normal HbAretic HbAr, patient samples were each analyzed per run. Although the precision samples are different, since they were run at different time periods, the precision results between the D-101™ Dual Program (6.5 Minutes) and the VARIANT ™ II Hemoglobin Aic (HbA1) Program are equivalent. A summary of combined comparative precision results is presented in the following precision table.
| D-10TM Dual (6.5 Minutes)HbA1c Program | VARIANTTM II Hemoglobin A1c(HbA1c) Program | |||
|---|---|---|---|---|
| Normal Sample | Diabetic Sample | Normal Sample | Diabetic Sample | |
| n= (number of samples) | 80 | 80 | 80 | 80 |
| Mean (%HbA1c) | 5.9 | 13.1 | 5.4 | 13.7 |
| Within run (%CV) | 0.8 | 0.3 | 1.8 | 0.7 |
| Total Precision (%CV) | 1.8 | 0.9 | 2.1 | 1.7 |
D-10™ Dual Program (6.5 Minutes) HbAj¿ vs. VARIANT™ II HbAi¿ Program - Precision
HbAz
The following precision table provides comparison data on the precision between D-1014 Dual Program (6.5 minutes) and VARIANT™ II ß -thalassemia Short Programs, each utilizing EDTA whole blood patient samples. The HbA2 tested samples had moderate (2.2-2.8) and high (4.6-5.4) % HbA2 content.
Method precision was performed using a protocol based on the NCCLS Evaluation protocol, Vol.12, No. 4, EP5-A (Feb. 1999) for the D-10TM Dual Program (6.5 minutes) and NCCLS Evaluation protocol, Vol.12, No. 4, EP5-T2 (Mar. 1992) for the VARIANT II ß-thalassemia Short Program. The protocols for both the D-10™ Dual Program and VARIANT II ßthalassemia Short Program are similar. Using these protocols, 40 runs (2 per day) were performed on one D-10™ (or VARIANT II) Hemoglobin Testing System over 20 working days. In each duplicate daily run, duplicate aliquots of low HbA2 and of high HbA2 patient samples were each analyzed in run. Although the precision samples are different, since they were run at different time periods, the precision results between the D-10™ Dual Program (6.5 minutes) and the VARIANT II ß-thalassemia Short Program are equivalent. A summary of combined comparative precision results is presented in the following precision table.
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Precision: (continued)
| D-10 Dual Program (6.5 Minutes) | VARIANT II β-thalassemia Short | |||
|---|---|---|---|---|
| HbA₂ | HbA₂ | |||
| Low Sample | High Sample | Low Sample | High Sample | |
| n= (number of samples) | 80 | 80 | 80 | 80 |
| Mean (%HbA₂) | 2.2 | 5.4 | 2.8 | 4.6 |
| Within run (%CV) | 4.5 | 1.7 | 1.6 | 0.9 |
| Total Precision (%CV) | 5.3 | 3.1 | 2.0 | 2.1 |
D-10™ Dual Program (6.5 minute HbA2) vs. VARIANT II (8-thalassemia Short(HbA2)-Precision
HbF
The following precision table provides comparison data on the precision between D-10™ Dual Program (6.5 minutes) and VARIANT™ II ß -thalassemia Short Programs, each utilizing EDTA whole blood patient samples. The HbF tested samples had moderate (1.6-2.1) and high (8.2-8.7) % HbF content.
Method precision was performed using a protocol based on the NCCLS Evaluation protocol, Vol.12, No. 4, EP5-A (Feb. 1999) for the D-10TM Dual Program (6.5 minutes) and NCCLS Evaluation protocol, Vol.12, No. 4, EP5-T2 (Mar. 1992) for the VARIANT II ß-thalassemia Short Program. The protocols for both the D-10TM Dual Program and VARIANT II ßthalassemia Short Program are similar. Using these protocols, 40 runs (2 per day) were performed on one D-10™ (or VARIANT II) Hemoglobin Testing System over 20 working days. In each duplicate daily run, duplicate aliquots of low HbF and of high HbF patient samples were each analyzed per run. Although the precision samples are different, since they were run at different time periods, the precision results between the D-10™ Dual Program (6.5 minutes) and the VARIANT II ß-thalassemia Short Program are equivalent. A summary of combined comparative precision results is presented in the following precision table.
| D-10 Dual Program (6.5 minutes) HbF | VARIANT II β-thalassemia Short HbF | |||
|---|---|---|---|---|
| Low Sample | High Sample | Low Sample | High Sample | |
| n= (number of samples) | 80 | 80 | 80 | 80 |
| Mean (%HbF) | 2.1 | 8.7 | 1.6 | 8.2 |
| Within run (%CV) | 1.7 | 1.4 | 2.1 | 0.6 |
| Total Precision (%CV) | 3.3 | 2.0 | 3.9 | 1.4 |
D-10™ Dual Program (6.5 minutes) HbF vs. VARIANT II ß-thalassemia Short (HbF) - Precision
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Linearity:
HbAjc
The following linearity table provides comparison data on the linearity and recovery analyses between D-10 TM Dual Program (6.5 Minutes) and VARIANT II Hemoglobin A1e Programs, each utilizing eight EDTA-based blood standards (n=2 for each standard). This second linearity study was performed to compare the D-10th Dual Program with the VARAINT II Hemoglobin AIc linearity using the same standards. The % Recovery for HbAic by the D-10 ™ Dual Program is essentially the same as the VARIANT II Hemoglobin A16 Program. The results are presented in the following linearity table.
The linear range as stated in the Instruction Manual on the D-10™ Dual Program is 3.7 to 18.4% HbAr which was performed in the first linearity study, each using a total of seven standards (n=2 for each standard) below, at, and substantially above blood levels of typical normal levels of hemoglobin Air and found in normal and diabetic patients.
| % Contribution | D-10 Dual Program (6.5 Minutes) | VARIANT II Hemoglobin A1c | |||||
|---|---|---|---|---|---|---|---|
| Normal | Diabetic | Theoretical % HbA1c | Observed % HbA1c | % Recovery | Theoretical % HbA1c | Observed % HbA1c | % Recovery |
| 100 | 0 | 3.8 | 3.8 | 100 | 4.0 | 4.0 | 100 |
| 90 | 10 | 5.3 | 5.3 | 100 | 5.4 | 5.4 | 100 |
| 80 | 20 | 6.8 | 6.7 | 98.5 | 6.8 | 6.7 | 98.5 |
| 67 | 33 | 8.8 | 8.6 | 97.7 | 8.8 | 8.7 | 98.9 |
| 50 | 50 | 11.3 | 11.1 | 98.2 | 11.3 | 11.3 | 100 |
| 33 | 67 | 13.8 | 13.7 | 99.3 | 13.8 | 13.7 | 99.3 |
| 20 | 80 | 15.7 | 15.7 | 100 | 15.8 | 15.9 | 100.6 |
| 0 | 100 | 18.6 | 18.6 | 100 | 19.0 | 19.0 | 100 |
D-10 " Dual Program (6.5 Minutes) vs. VARIANT II Hemoglobin A12 Linearity
HbAz
The following linearity table provides comparison data on the linearity and recovery analyses between D-10 ™ Dual Program (6.5 minutes) and VARIANT II B-thalassemia, each utilizing eight EDTA-based blood standards (n=2 for each standard). This second linearity study was performed to compare the D-10 ™ Dual Program with the VARAINT II ß-thalassemia Short Program linearity using the same standards. The % Recovery for HbA2 by the D-10 100 Dual Program is essentially the same as the VARIANT II ß-thalassemia Short Program (HbA2). Results are presented in the linearity table below.
The linear range as stated in the Instruction Manual on the D-10 ™ Dual Program is 1.5 to 11.4% HbA2 which was performed in the first linearity study, each using a total of seven standards (n=2 for each standard) below, at, and substantially above blood levels of typical normal levels of hemoglobin A. and found in normal patients or patients with ß-thalassemia.
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Linearity: (continued)
| D-10 Dual Program (6.5 Minutes) | VARIANT II - thalassemia Short | ||||||
|---|---|---|---|---|---|---|---|
| % ContributionLow | High | Theoretical% HbA₂ | Observed% HbA₂ | %Recovery | Theoretical% HbA₂ | Observed% HbA₂ | %Recovery |
| 100 | 0 | 1.7 | 3.8 | 100 | 1.8 | 1.8 | 100 |
| 90 | 10 | 2.5 | 2.5 | 100 | 2.6 | 2.6 | 100 |
| 80 | 20 | 3.4 | 3.1 | 91.2 | 3.4 | 3.3 | 97.1 |
| 67 | 33 | 4.5 | 4.2 | 93.3 | 4.4 | 4.3 | 97.1 |
| 50 | 50 | 6.0 | 5.8 | 96.7 | 5.7 | 5.6 | 98.3 |
| 33 | 67 | 7.4 | 7.2 | 97.3 | 7.0 | 6.9 | 98.6 |
| 20 | 80 | 8.6 | 8.5 | 98.8 | 8.1 | 8.1 | 100 |
| 0 | 100 | 10.3 | 10.3 | 100 | 9.7 | 9.7 | 100 |
D-10™ Dual Program (6.5 Minutes) vs. VARIANT II Hemoglobin A16 - Linearity
HPF
The following linearity table provides comparison data on the linearity and recovery analyses between D-10 TM Dual Program (6.5 minutes) and VARIANT TM II B-thalassemia, each utilizing eight EDTA-based blood standards (n=2 for each standard). This second linearity study was performed to compare the D-10 TM Dual Program with the VARAINT ™ II B-thalassemia Short Program linearity using the same standards. The % Recovery for HbF by the D-10 TM Dual Program is essentially the same as the VARIANT II ß-thalassemia Program. The results are presented in the following linearity table.
The linear range as stated in the Instruction Manual on the D-10 ™ Dual Program is 0.8 to 16.5% HbF which was performed in the first linearity study, each using a total of seven standards (n=2 for each standard) below, at, and substantially above blood levels of typical normal levels of hemoglobin F and found in normal patients or patients with ß-thalassemia.
| D-10 Dual Program (6.5 Minutes HbF) | VARIANT II β-thalassemia Short | ||||||
|---|---|---|---|---|---|---|---|
| % Contribution | Theoretical% HbF | Observed% HbF | %Recovery | Theoretical% HbF | Observed% HbF | %Recovery | |
| Low | High | 0.4 | 0.4 | 100 | 0.1 | 0.1 | 100 |
| 100 | 0 | ||||||
| 95 | 5 | 1.4 | 1.5 | 107.1 | 1.0 | 1.1 | 110.0 |
| 90 | 10 | 2.4 | 2.7 | 112.5 | 1.9 | 1.7 | 89.5 |
| 80 | 20 | 4.5 | 4.8 | 106.7 | 3.7 | 4.0 | 108.1 |
| 67 | 33 | 7.2 | 7.7 | 106.9 | 6.2 | 6.6 | 106.5 |
| 50 | 50 | 10.8 | 11.1 | 102.8 | 9.4 | 9.9 | 105.3 |
| 33 | 67 | 14.4 | 14.6 | 101.4 | 12.6 | 13.0 | 103.2 |
| 20 | 80 | 17.4 | 17.5 | 100.6 | 15.2 | 15.5 | 102.0 |
| 0 | 100 | 22.0 | 22.0 | 100 | 19.3 | 19.3 | 100 |
D-10 ™ Dual Program (6.5 Minutes) vs. VARIANT II {-thalassemia Short (HbF) - Linearity
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Specificity and Interference Testing
HbA1c
In evaluating the specificity of the Bio-Rad D-10™ Dual Program for %HbAre in EDTAtreated blood samples, two closely related but chemical derived analogs of HbA1, where evaluated as part of a detailed analytical specificity study. The influence of carbamylated hemoglobin was studied by spiking specimens with sodium cyanate until the carbamylated hemoglobin levels increased to a range of 2.0%. Also, influence of unstable labile hemoglobin Ate was studied by spiking samples with glucose until unstable labile Ate in hemoglobin reached 3.5%. As was the case for the predicate Bio-Rad VARIANT™ II HbA1c system, the results with this new Rad D-10101 Dual Program system demonstrated that the final measurement of %HbAre at normal and diabetic levels was not significantly influenced by either added carbamylated hemoglobin or added glucose-labile hemoglobin Aic at the above indicated limits.
Additional normal and diabetic blood samples were obtained as patient bloods that were anticoagulated with EDTA in the standard manner. In three separate trials of patient pools or individual blood samples: a) concentrated bilirubin was added to a final level of 20 mg/dL: b) concentrated lipids were added to a final level of 5680 mg/dL; and c) additional dipotassium EDTA was added to a concentration of ~1980 mg/dL (11x the normal level) to determine the effect of high concentrations of EDTA that can occur in cases of "short draws." For the final measurement of normal and high diabetic HbA1c in blood samples, neither the Bio-Rad D-10TM Dual Program system nor cleared predicate Bio-Rad VARIANT™ II HbAic Program system were influenced by these excess biochemicals or excess EDTA anticoagulant, as illustrated in the interference evaluation table on the next page.
HbA2
In evaluating for specificity of the Bio-Rad D-10™ Dual Program for %HbA2 in EDTAtreated blood samples, additional normal, moderate and high blood %HbA2 samples were obtained as patient bloods that were anticoagulated with EDTA in the standard manner. In three separate trials of patient pools or individual blood samples: a) concentrated bilirubin was added to a final level of 20 mg/dL; b) concentrated lipids were added to a final level between 5680 mg/dL; and c) additional dipotassium EDTA was added to a concentration of ~1980 mg/dL (11x the normal level) to determine the effect of high concentrations of EDTA that can occur in cases of "short draws." For the final measurement of normal, moderate and high HbA2 in blood samples, neither the Bio-Rad D-10130 Dual Program system nor the cleared predicate Bio-Rad VARIANT II 8-thalassemia Program system were influenced significantly by these excess biochemicals or excess EDTA anticoagulant, as illustrated in the interference evaluation table on the next page.
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Specificity and Interference Testing - continued
HbF
The HbF assay was evaluated using the Bio-Rad D-10™ Dual Program system as part of a detailed analytical specificity study. First the influence of an unstable complex of glucose & hemoglobin known as labile Hemoglobin A16 (Which chromatographs in proximity to HbF) was studied by spiking samples with glucose until labile A . in Hemoglobin reached 0-2.6%. Final measurement of HbF in these blood-based human specimens was not influenced significantly by labile Hemoglobin A te at the above-indicated limits, as was the case also for the predicate, the Bio-Rad VARIANT™ II ß-thalassemia Program system.
In evaluating for specificity of this Bio-Rad D-10™ Dual Program system for %HbF in EDTA-treated blood samples, additional normal, moderate and high blood samples were obtained as patient bloods that were anticoagulated with EDTA in the standard manner. In three separate trials of patient pools or individual blood samples: a) concentrated bilirubin was added to a final level of 20 mg/dL; b) concentrated lipids were added to a final level between 5680 and 6000 mg/dL; and c) additional dipotassium EDTA was added to a concentration of ~1980 mg/dL (11x the normal level) to determine the effect of high concentrations of EDTA that can occur in cases of "short draws." For the final measurement of HbF, as well as HbA1c and HbA2, neither the Bio-Rad D-10 Dual Program system, nor cleared predicate Bio-Rad VARIANT II ß-thalassemia Program system were influenced significantly by these excess biochemicals or excess EDTA anticoagulant, as illustrated in the interference evaluation table below.
| Interfering Substance | D-10 TM Dual Program(Extended)(HbA1c & HbA2/F) | VARIANT TM IIHemoglobin A1c(HbA1c) | VARIANT TM II β-thalassemia Short(HbA2/F) |
|---|---|---|---|
| Potential Labile Hb(glucose + Hb)Interference | No significantinterference up to 3.5%Labile Hb on HbA1c | No significantinterference up to4.8% Labile Hb onHbA1c | Not Applicable |
| Potential Labile Hb(glucose + Hb)Interference | No significantinterference up to 2.6%Labile Hb on HbF | Not Applicable | Not Applicable |
| Bilirubin | No interference up to20 mg/dL | No interference up to20 mg/dL | No interference up to20 mg/dL |
| Lipids(Triglycerides) | No interference up to5680 mg/dL | No interference up to6000 mg/dL | No interference up to4600 mg/dL |
| EDTA | No interference up to11X EDTA | No interference up to11X EDTA | No interference up to11X EDTA |
Summary of Testing for Interfering Substances:
{14}------------------------------------------------
Conclusion:
The similarities of the intended use and the general performance characteristics and results of the The smilliarthed and evaluated Bio-Rad D-10™ Dual Program system are nearly identical to or newily desorrocd and Crafacted 210 reacleared program systems [i.e., the Bio-Rad logical extensions of the two oceared program and the Bio-Rad VARIANT T™ II B-thalassemia Short VARINT - In Tremogious: 11] - 10gs sed on the use of the same HPLC technology, and the I tograin. - Theo, one most of the correlation, precision, linearity, and interfering substances tests versus the corresponding results obtained with the two predicate systems that the Substances tests versus the occreepom system is substantially equivalent to these 2 cleared and currently marketed predicate systems.
{15}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/15/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Bio-Rad Laboratories, Inc. c/o Alfredo J. Quattrone, Ph.D., D.A.B.T. Third Party 510(k) Review Coordinator California Department of Health Food & Drug Branch 1500 Capitol Avenue Mailstop 7602 Sacramento, CA 95814
JUN - 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K041444
Trade/Device Name: Bio-Rad D-10TM Dual Program Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: May 28, 2004 Received: June 1, 2004
Dear Dr. Quattrone
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associous to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dieres provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may be subject to bach adde of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i tease be day nou a carreraination that your device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{16}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin mailing of substantial equivalence of your device to a legally prematication: The PDF Intentigssification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you destic specific monitiation as advertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Viro Diagnostic De Hoo Dranding by reference to premarket notification" (21CFR Part 807.97). Tegulation chittled, "Misoration on your responsibilities under the Act from the I ou may of and Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Stain M. Cooper, U.S., DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041444 Bio-Rad D-10™ Dual Program Device Name: The Bio-Rad D-10™ Dual Program system is intended Indications For Use: for the percent determination of hemoglobins A1c, A2, and F and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC). Measurement of the percent hemoglobin As is effective in monitoring long-term glucose control in individuals with diabetes mellitus, and measurement of the percent HbA2 and HbF is effective in long-term monitoring of ß—thalassemias (i.e., hereditary hemolytic anemias characterized by decreased synthesis of one or more types of abnormal hemoglobin polypeptide chains). Detection of hemoglobin thalassemia variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants. The Bio-Rad D-10TM Dual Program is intended for Professional Use Only. For in vitro diagnostics use.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K04,444
Page 1 of
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).