(8 days)
No
The summary describes a device based on High Performance Liquid Chromatography (HPLC) for quantitative analysis of hemoglobins. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The analysis is based on established chromatographic separation principles.
No
This device is an in vitro diagnostic device used for measurement and detection of hemoglobins. It does not provide therapy or treatment.
Yes
The device is described as "intended for the percent determination of hemoglobins A1c, A2, and F and for the detection of abnormal hemoglobins in human whole blood," and its measurements are effective in "monitoring long-term glucose control in individuals with diabetes mellitus" and "long-term monitoring of ß—thalassemias." It also enables "presumptive identification of [thalassemia] variants." These uses clearly indicate its role in diagnosing and monitoring medical conditions.
No
The device description explicitly states it is a "new device system that utilizes the principles of high performance liquid chromatography (HPLC)" and includes components like an "ion exchange cartridge" and "reagent kit," indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostics use."
Furthermore, the device is intended for the determination of hemoglobins in human whole blood, which is a biological specimen, and the results are used for monitoring and detection of medical conditions (diabetes mellitus and ß—thalassemias), which aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 Aic 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.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JPD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use Only. For in vitro diagnostic use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Study:
- HbA1c Correlation: Method correlation was performed between the Bio-Rad D-10™ Dual Program (6.5 minutes) and VARIANT™ II Hemoglobin A Program.
- Sample Size: 40 EDTA whole blood samples.
- Sample Range: 4.7% to 11.2% HbA1c.
- Key Results (Least Squares Regression): n=40, r²=0.9843, Slope=0.9906, Intercept=0.4310.
- HbA2 Correlation: Method correlation was performed between the Bio-Rad D-10™ Dual Program (6.5 minutes) and VARIANT™ II β-thalassemia Short Program.
- Sample Size: 40 EDTA whole blood samples.
- Sample Range: 1.9% to 8.9% HbA2.
- Key Results (Least Squares Regression): n=40, r²=0.9832, Slope=1.0898, Intercept=-0.2407.
- HbF Correlation: Method correlation was performed between the Bio-Rad D-10™ Dual Program (6.5 minutes) and VARIANT™ II β-thalassemia Short Program.
- Sample Size: 40 EDTA whole blood samples.
- Sample Range: 0% to 12.91% HbF.
- Key Results (Least Squares Regression): n=40, r²=0.9959, Slope=0.9497, Intercept=-0.1785.
Precision Study:
- HbA1c Precision: Comparison between D-10™ Dual Program (6.5 Minutes) and VARIANT™ II Hemoglobin A Program.
- Protocol: NCCLS Evaluation protocol, Vol.12, No. 4, EP5-A (Feb. 1999) for D-10 Dual Program and NCCLS Evaluation protocol, Vol.12, No. 4, EP5-T2 (Mar. 1992) for VARIANT II Hemoglobin Aic Program.
- Runs: 40 runs (2 per day) over 20 working days. Duplicate aliquots of normal and diabetic HbA1c patient samples analyzed per run.
- Normal Sample: Mean=5.9% HbA1c, Within run %CV=0.8, Total Precision %CV=1.8 (D-10 Dual); Mean=5.4% HbA1c, Within run %CV=1.8, Total Precision %CV=2.1 (VARIANT II).
- Diabetic Sample: Mean=13.1% HbA1c, Within run %CV=0.3, Total Precision %CV=0.9 (D-10 Dual); Mean=13.7% HbA1c, Within run %CV=0.7, Total Precision %CV=1.7 (VARIANT II).
- Key Result: Precision results between the D-10™ Dual Program (6.5 Minutes) and the VARIANT™ II Hemoglobin Aic (HbA1c) Program are equivalent.
- HbA2 Precision: Comparison between D-10™ Dual Program (6.5 minutes) and VARIANT™ II β-thalassemia Short Programs.
- Protocol: NCCLS Evaluation protocol, Vol.12, No. 4, EP5-A (Feb. 1999) for D-10 Dual Program and NCCLS Evaluation protocol, Vol.12, No. 4, EP5-T2 (Mar. 1992) for VARIANT II β-thalassemia Short Program.
- Runs: 40 runs (2 per day) over 20 working days. Duplicate aliquots of low and high HbA2 patient samples analyzed per run.
- Low Sample: Mean=2.2% HbA2, Within run %CV=4.5, Total Precision %CV=5.3 (D-10 Dual); Mean=2.8% HbA2, Within run %CV=1.6, Total Precision %CV=2.0 (VARIANT II).
- High Sample: Mean=5.4% HbA2, Within run %CV=1.7, Total Precision %CV=3.1 (D-10 Dual); Mean=4.6% HbA2, Within run %CV=0.9, Total Precision %CV=2.1 (VARIANT II).
- Key Result: Precision results between the D-10™ Dual Program (6.5 minutes) and the VARIANT II β-thalassemia Short Program are equivalent.
- HbF Precision: Comparison between D-10™ Dual Program (6.5 minutes) and VARIANT™ II β-thalassemia Short Programs.
- Protocol: NCCLS Evaluation protocol, Vol.12, No. 4, EP5-A (Feb. 1999) for D-10 Dual Program and NCCLS Evaluation protocol, Vol.12, No. 4, EP5-T2 (Mar. 1992) for VARIANT II β-thalassemia Short Program.
- Runs: 40 runs (2 per day) over 20 working days. Duplicate aliquots of low and high HbF patient samples analyzed per run.
- Low Sample: Mean=2.1% HbF, Within run %CV=1.7, Total Precision %CV=3.3 (D-10 Dual); Mean=1.6% HbF, Within run %CV=2.1, Total Precision %CV=3.9 (VARIANT II).
- High Sample: Mean=8.7% HbF, Within run %CV=1.4, Total Precision %CV=2.0 (D-10 Dual); Mean=8.2% HbF, Within run %CV=0.6, Total Precision %CV=1.4 (VARIANT II).
- Key Result: Precision results between the D-10™ Dual Program (6.5 minutes) and the VARIANT II β-thalassemia Short Program are equivalent.
Linearity Study:
- HbA1c Linearity: Comparison between D-10™ Dual Program (6.5 Minutes) and VARIANT II Hemoglobin A1c Programs.
- Standards: Eight EDTA-based blood standards (n=2 for each standard).
- Key Results: The % Recovery for HbAic by the D-10 ™ Dual Program is essentially the same as the VARIANT II Hemoglobin A1c Program. Linear range: 3.7 to 18.4% HbA1c for the D-10 Dual Program.
- HbA2 Linearity: Comparison between D-10™ Dual Program (6.5 minutes) and VARIANT II β-thalassemia.
- Standards: Eight EDTA-based blood standards (n=2 for each standard).
- Key Results: The % Recovery for HbA2 by the D-10 ™ Dual Program is essentially the same as the VARIANT II ß-thalassemia Short Program. Linear range: 1.5 to 11.4% HbA2 for the D-10 Dual Program.
- HbF Linearity: Comparison between D-10™ Dual Program (6.5 minutes) and VARIANT™ II ß-thalassemia.
- Standards: Eight EDTA-based blood standards (n=2 for each standard).
- Key Results: The % Recovery for HbF by the D-10 ™ Dual Program is essentially the same as the VARIANT II ß-thalassemia Program. Linear range: 0.8 to 16.5% HbF for the D-10 Dual Program.
Specificity and Interference Testing:
- HbA1c, HbA2, HbF: Evaluation of interference from carbamylated hemoglobin, unstable labile hemoglobin A1c, bilirubin, lipids, and excess EDTA.
- HbA1c: Not significantly influenced by added carbamylated hemoglobin (up to 2.0%) or added glucose-labile hemoglobin (up to 3.5%).
- General Interference: For HbA1c, HbA2, and HbF, neither the Bio-Rad D-10™ Dual Program system nor the predicate systems were influenced significantly by concentrated bilirubin (up to 20 mg/dL), concentrated lipids (up to 5680 mg/dL for D-10; up to 6000 mg/dL for predicate HbA1c; up to 4600 mg/dL for predicate HbA2/F), or additional dipotassium EDTA (~1980 mg/dL or 11x the normal level).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Precision metrics provided are %CV, Slope, Intercept, and r2.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Laboratories
Diagnostics Group
4000 Alfred Nobel Drive,
Hercules, California 94547
Phone: (510) 741-5309
FAX: (510) 741-6471 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackie Buckley
Regulatory 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] and
HbA₂: Hemoglobin A₂ Quantitation
[21CFR 864.7400 / Prod. Code: JPD] |
| Predicate Devices: | HbA₁c: VARIANT™ II Hemoglobin A₁c Program
Bio-Rad Laboratories
[K984268; 12/17/98] |
| | HbA₂/F: VARIANT™ II β-thalassemia Short Program
Bio-Rad Laboratories
[K991127; 06/10/99] |
| | Presumptive Hemoglobin Identification:
VARIANT™ II β-thalassemia Short Program
Bio-Rad Laboratories
[K991127; 06/10/99] |
| | Special Instrument Requirement:
Bio-Rad D-10™ Hemoglobin Testing System
[K031043; 08/27/03] |
1
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.
2
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:
3
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 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).
The Bio-Rad D-10 Dual Program is intended
for in Professional Use only. For in vitro
diagnostic Use. | The VARIANT II Hemoglobin A1c Program is
intended for the determination of hemoglobin
A1c in human whole blood using ion-exchange
high performance liquid chromatography
(HPLC).
The VARIANT II Hemoglobin A1c Program is
intended for use only with the Bio-Rad
VARIANT II Hemoglobin Testing System.
For in vitro diagnostic use. |
| Indication(s) for Use | 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
are effective in monitoring of β-thalassemia
(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. | Measurement of the percent hemoglobin A1c is
effective in monitoring long-term glucose control
in individuals with diabetes mellitus. |
| Assay Principle | Cation exchange high performance liquid
chromatography | Cation exchange high performance liquid
chromatography |
| Sample Type | Human anticoagulated whole blood (EDTA) | Human anticoagulated whole blood (EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Standardization | Traceable to the Diabetes Control and
Complications Trial (DCCT) reference method
and IFCC. Certified via the National
Glycohemoglobin Standardization Program
(NGSP) for HbA1c. | Traceable to the Diabetes Control and
Complications Trial (DCCT) reference method
and IFCC. Certified via the National
Glycohemoglobin Standardization Program
(NGSP) for HbA1c. |
| Results | Quantitative Area % HbA1c | Quantitative Area % HbA1c |
| Time to process
sample | 6.5 minutes | 3.0 minutes |
| Expected Value
Range | 4.27 – 6.07 % HbA1c | 4.27 – 6.07 % HbA1c |
| Linearity | 3.7 – 18.4 % HbA1c | 1.3 – 18.9% HbA1c |
4
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 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).
The Bio-Rad D-10 Dual Program is intended
for Professional Use Only. For in vitro
diagnostic use. | The VARIANT II β-thalassemia Short Program
is intended for the separation and area percent
determinations of hemoglobins A2 and F, and
as an aid in the identification of abnormal
hemoglobins in whole blood using ion-
exchange high performance liquid
chromatography.
The VARIANT II β-thalassemia Short Program
is intended for use only with the Bio-Rad
VARIANT II Hemoglobin Testing System.
For in vitro diagnostic use. |
| Indication(s) for Use | 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 are effective in monitoring of β-
thalassemia (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. | Measurement of the percent HbA2 and HbF are
effective in monitoring of β-thalassemia (i.e.,
hereditary hemolytic anemias characterized by
decreased synthesis of one or more types of
abnormal hemoglobin polypeptide chains).
Identification of hemoglobin thalassemia
variants such as hemoglobins S, C, D and E by
HPLC is effective in presumptive identification
of these variants. |
| Assay Principle | Cation exchange high performance liquid
chromatography | Cation exchange high performance liquid
chromatography |
| Sample Type | Human anticoagulated whole blood (EDTA) | Human anticoagulated whole blood (EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Standardization | The Joint Committee on Traceability in
Laboratory Medicine has not identified a
higher order reference method or reference
material for the quantitation of HbA2 and HbF | The Joint Committee on Traceability in
Laboratory Medicine has not identified a higher
order reference method or reference material for
the quantitation of HbA2 and HbF |
| Results | Quantitative Area % HbA2 | Quantitative Area % HbA2 |
| Time to process
sample | 6.5 minutes | 6.5 minutes |
| Expected Value
Range | 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 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).
The Bio-Rad D-10 Dual Program is intended
for Professional Use Only. For in vitro
diagnostic use. | The VARIANT II β-thalassemia Short Program
is intended for the separation and area percent
determinations of hemoglobins A2 and F, and
as an aid in the identification of abnormal
hemoglobins in whole blood using ion-
exchange high performance liquid
chromatography.
The VARIANT II β-thalassemia Short Program
is intended for use only with the Bio-Rad
VARIANT II Hemoglobin Testing System.
For in vitro diagnostic use. |
| Indication(s) for Use | 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 are effective in monitoring of β-
thalassemia (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. | Measurement of the percent HbA2 and HbF are
effective in monitoring of β-thalassemia (i.e.,
hereditary hemolytic anemias characterized by
decreased synthesis of one or more types of
abnormal hemoglobin polypeptide chains).
Identification of hemoglobin thalassemia
variants such as hemoglobins S, C, D and E by
HPLC is effective in presumptive identification
of these variants. |
| Assay Principle | Cation exchange high performance liquid
chromatography | Cation exchange high performance liquid
chromatography |
| Sample Type | Human anticoagulated whole blood (EDTA) | Human anticoagulated whole blood (EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Standardization | The Joint Committee on Traceability in
Laboratory Medicine has not identified a
higher order reference method or reference
material for the quantitation of HbA2 and HbF | The Joint Committee on Traceability in
Laboratory Medicine has not identified a higher
order reference method or reference material for
the quantitation of HbA2 and HbF |
| Results | Quantitative Area % HbF | Quantitative Area % HbF |
| Time to process
sample | 6.5 minutes | 6.5 minutes |
| Expected Value
Range | 0 - 0.8% HbF |