(17 days)
Not Found
No
The device description and performance studies focus on the analytical method (HPLC) and the automation features (rack loader), with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: This device is an in-vitro diagnostic device used for determining the percentage of specific hemoglobins in human whole blood. It is an analytical tool for diagnosis and monitoring, not a device that directly provides therapy or treatment.
Yes
The device determines hemoglobin A1c, A2, and F in human whole blood, aiding in monitoring glucose control for diabetics, screening for ß-thalassemias, and detecting abnormal hemoglobins, which are all diagnostic purposes. The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use."
No
The device description clearly states it is a "fully automated analyzer consisting of a single module that provides an integrated method for sample preparation, and determination of specific hemoglobins in whole blood." This indicates a physical hardware device, not software only. The submission also describes a new hardware component, the D-10 Rack Loader.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use." and "For in vitro diagnostic use."
- Intended Use: The device is intended for the "percent determination of hemoglobin A1c in human whole blood" and "percent determination of hemoglobins A1c, A2 and F, and for the detection of abnormal hemoglobins in human whole blood." These are tests performed on biological samples (whole blood) outside of the body to provide information for diagnosis or monitoring.
- Device Description: The device is described as a "fully automated analyzer" that performs "sample preparation, and determination of specific hemoglobins in whole blood" using "high performance liquid chromatography." This aligns with the typical description of an in vitro diagnostic device.
- Professional Use Only: The intended user is "Professional Use Only," which is common for IVD devices used in clinical settings.
N/A
Intended Use / Indications for Use
The D-10TM Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC).
The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.
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.
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 screening 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 variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JPD
Device Description
The Bio-Rad Hemoglobin Testing System is a fully automated analyzer consisting of a single module that rovides an integrated method for sample preparation, and determination of specific hemoglobins in whole blood. The Bio-Rad Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g. A2, F and A1c in whole blood). The separation is based on the principles of high performance liquid chromatography. The system can accommodate 1 to 10 samples per run using a single rack currently.
The new feature in this submission is the optional D-10 Rack Loader which will be available for use with the D-10 Hemoglobin Testing System. The D-10 Rack Loader accommodates 5 racks and automatically transports each rack into and out of the D-10 System. The D-10 Rack Loader offers continuous loading, allowing the operator to insert or remove racks during a run.
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.
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:
- D-10 Hemoglobin HbA1c Program (3 minute): Method correlation between Bio-Rad D-10 Hemoglobin AIc Program with D-10 Rack Loader and D-10 Hemoglobin A1c Program without D-10 Rack Loader was evaluated using 40 EDTA whole blood samples ranging from 5.1% to 14.3% HbA1c. Results (Least Squares): n=40, r2=0.9950, Slope=0.9415, Intercept=0.2714.
- D-10 Dual Program - Hemoglobin A1c (6.5 minute): Method correlation between Bio-Rad D-10 Dual Program with D-10 Rack Loader and D-10 Dual Program without D-10 Rack Loader was evaluated using 40 EDTA whole blood samples ranging from 5.1% to 14.3% HbA1c. Results (Least Squares): n=40, r2=0.9956, Slope=0.9827, Intercept=0.1208.
- D-10 Dual Program - Hemoglobin A2 (6.5 minute): Method correlation between Bio-Rad D-10 Dual Program with D-10 Rack Loader and D-10 Dual Program without Rack Loader was evaluated with 39 EDTA whole blood samples ranging from 2.1% - 11.8% HbA2. Results (Least Squares): n=39, r2=0.9975, Slope=0.9902, Intercept=0.2476.
- D-10 Dual Program - Hemoglobin F (6.5 minute): Method correlation between Bio-Rad D-10 Dual Program with D-10 Rack Loader and D-10 Dual Program without D-10 Rack Loader was evaluated with 39 EDTA whole blood samples ranging from 0.8% - 17.3% HbF. Results (Least Squares): n=39, r2=0.9956, Slope=1.0188, Intercept=-0.3863.
Precision:
- D-10 Hemoglobin A1c Program (3 minute): Precision comparison between D-10 Hemoglobin A1c Program with D-10 Rack Loader and without D-10 Rack Loader using EDTA whole blood patient samples.
- Protocol based on NCCLS Evaluation protocol EP5-A2 (with Rack Loader) and EP5-T2 (without Rack Loader).
- With Rack Loader: 400 samples (Normal), 400 samples (Diabetic). Mean %HbA1c: 5.6 (Normal), 11.0 (Diabetic). Within run %CV: 0.6 (Normal), 0.6 (Diabetic). Total Precision %CV: 1.5 (Normal), 1.4 (Diabetic).
- Without Rack Loader: 80 samples (Normal), 80 samples (Diabetic). Mean %HbA1c: 5.9 (Normal), 13.1 (Diabetic). Within run %CV: 0.8 (Normal), 0.3 (Diabetic). Total Precision %CV: 1.8 (Normal), 0.9 (Diabetic).
- Key Result: Precision results between the D-10 Hemoglobin A1c Program with D-10 Rack Loader and without D-10 Rack Loader are equivalent.
- D-10 Dual Program - HbA1c (6.5 minutes): Precision comparison between D-10 Dual Program (HbA1c) with Rack Loader and without Rack Loader using EDTA whole blood patient samples.
- Protocol based on NCCLS Evaluation protocol EP5-A2 (with Rack Loader) and EP5-A (without Rack Loader).
- With Rack Loader: 400 samples (Normal), 400 samples (Diabetic). Mean %HbA1c: 5.5 (Normal), 10.6 (Diabetic). Within run %CV: 0.7 (Normal), 0.4 (Diabetic). Total Precision %CV: 1.5 (Normal), 1.2 (Diabetic).
- Without Rack Loader: 80 samples (Normal), 80 samples (Diabetic). Mean %HbA1c: 5.9 (Normal), 13.1 (Diabetic). Within run %CV: 0.8 (Normal), 0.3 (Diabetic). Total Precision %CV: 1.8 (Normal), 0.9 (Diabetic).
- Key Result: Precision results between the D-10 Dual Program with D-10 Rack Loader and without D-10 Rack Loader are equivalent.
- D-10 Dual Program HbA2 (6.5 minutes): Precision comparison between D-10 Dual Program (HbA2) with D-10 Rack Loader and without D-10 Rack Loader using EDTA whole blood patient samples.
- Protocol based on NCCLS Evaluation protocol EP5-A2 (with Rack Loader) and EP5-A (without Rack Loader).
- With Rack Loader: 400 samples (Low), 400 samples (High). Mean %HbA2: 2.9 (Low), 4.9 (High). Within run %CV: 1.8 (Low), 1.2 (High). Total Precision %CV: 3.6 (Low), 3.6 (High).
- Without Rack Loader: 80 samples (Low), 80 samples (High). Mean %HbA2: 2.2 (Low), 5.4 (High). Within run %CV: 4.5 (Low), 1.7 (High). Total Precision %CV: 5.3 (Low), 3.1 (High).
- Key Result: Precision results between the D-10 Dual Program with D-10 Rack Loader and without D-10 Rack Loader are equivalent.
- D-10 Dual Program -- HbF (6.5 minutes): Precision comparison between D-10 Dual Program (HbF) with D-10 Rack Loader and without D-10 Rack Loader using EDTA whole blood patient samples.
- Protocol based on NCCLS Evaluation protocol EP5-A2 (with Rack Loader) and EP5-A (without Rack Loader).
- With Rack Loader: 400 samples (Low), 400 samples (High). Mean %HbF: 1.4 (Low), 6.6 (High). Within run %CV: 2.1 (Low), 0.8 (High). Total Precision %CV: 2.9 (Low), 1.8 (High).
- Without Rack Loader: 80 samples (Low), 80 samples (High). Mean %HbF: 2.1 (Low), 8.7 (High). Within run %CV: 1.7 (Low), 1.4 (High). Total Precision %CV: 3.3 (Low), 2.0 (High).
- Key Result: Precision results between the D-10 Dual Program with D-10 Rack Loader and without D-10 Rack Loader are equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
Koboool/
Attachment 4
JAN 2 0 2006
Summary of Safety and Effectiveness Bio-Rad Laboratories, Inc.
1
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, Inc.
Clinical System Division
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: | December 30, 2005 |
| Device Name: | Bio-Rad D-10 TM Dual Program
Bio-Rad D-10 TM Hemoglobin A1c Program
on the D-10 Hemoglobin System with D-10 Rack
Loader |
| Classification Name: | HbA 1c : Assay, Glycosylated Hemoglobin
[21CFR 864.7470 / Prod. Code LCP] and
HbA 2 : Hemoglobin A 2 Quantitation
[21CFR 864.7400 / Prod. Code: JPD] |
| Predicate Devices: | D-10 Hemoglobin A1c Program
Bio-Rad Laboratories, Inc.
[K031043, August 27, 2003]
D-10 Dual Program
Bio-Rad Laboratories, Inc
[K041444, June 9, 2004] |
2
Indications for Use Statements and Intended Uses:
The D-10TM Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC).
The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.
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.
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 screening 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 variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants.
3
New Device Description
The Bio-Rad Hemoglobin Testing System is a fully automated analyzer consisting of a single module that rovides an integrated method for sample preparation, and determination of specific hemoglobins in whole blood. The Bio-Rad Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g. A2, F and A1c in whole blood). The separation is based on the principles of high performance liquid chromatography. The system can accommodate 1 to 10 samples per run using a single rack currently.
The new feature in this submission is the optional D-10 Rack Loader which will be available for use with the D-10 Hemoglobin Testing System. The D-10 Rack Loader accommodates 5 racks and automatically transports each rack into and out of the D-10 System. The D-10 Rack Loader offers continuous loading, allowing the operator to insert or remove racks during a run.
Technical Characteristics Compared to Predicate
The Bio-Rad D-1018 Hemoglobin A1c Program and the D-10 Dual Program run on the D-10 Hemoglobin Testing System with D-10 Rack Loader have the same basic technical characteristics as the predicates D-10 Hemoglobin A1c Program (k) 031043 and D-10 Dual Program (k)041444 run on the D-10 Hemoglobin Testing System. There are three main differences between the D-10 Hemoglobin Testing System with the new D-10 Rack Loader. The technical characteristics are summarized in the following tables:
4
D-10™ Hemoglobin A1c (k)031043
| Summary of Technological Characteristic Similarities in Comparison to Predicate Device | ||
|---|---|---|
| Characteristics | New Device: | Predicate Device: |
| D-10TM Hemoglobin A1c Program run on the | D-10TM Hemoglobin A1c Program run on the | |
| D-10 Hemoglobin Testing System with | D-10 Hemoglobin Testing System without the | |
| D-10 Rack Loader | D-10 Rack Loader | |
| Intended Use(s) | The Bio-Rad Hemoglobin A1c Program is | |
| intended for the percent determination of | ||
| hemoglobin A1c in human whole blood using | ||
| ion-exchange high-performance liquid | ||
| chromatography (HPLC). The D-10 | ||
| Hemoglobin A1c Program is intended for use | ||
| only with the Bio-Rad D-10 Hemoglobin | ||
| Testing System. |
For In Vitro Diagnostic Use. | The Bio-Rad Hemoglobin A1c Program is
intended for the percent determination of
hemoglobin A1c in human whole blood using
ion-exchange high-performance liquid
chromatography (HPLC). The D-10
Hemoglobin A1c Program is intended for use
only with the Bio-Rad D-10 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. | Measurement of the percent hemoglobin A1c is
effective n 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 | 3.0 minutes | 3.0 minutes |
5
D-10™ Hemoglobin A1c (k)031043
.
.
:
| Summary of Technological Characteristic Differences in Comparison to Predicate Device | ||
|---|---|---|
| Characteristics | New Device: | |
| D-10™ Hemoglobin A1c Program run on the | ||
| D-10 Hemoglobin Testing System with | ||
| D-10 Rack Loader | Predicate Device: | |
| D-10™ Hemoglobin A1c Program run on the | ||
| D-10 Hemoglobin Testing System without the | ||
| D-10 Rack Loader | ||
| Software version | 3.5 | 3.00 |
| Number of Racks that | ||
| can be run. | 5 Racks of 10 EDTA whole blood tubes | 1 rack of 10 EDTA whole blood tubes |
| Rack insertion into | ||
| D-10 Hemoglobin | ||
| Testing System | Automated | Manual |
| D-10TM Dual Program (k)0414444 | ||
| Summary of Technological Characteristic Similarities in Comparison to Predicate Device | ||
| Characteristics | New Device: | Predicate Device: |
| Intended Uses | Bio-Rad D-10TM Dual Program run on the D- | |
| 10 Hemoglobin Testing System with | ||
| D-10 Rack Loader |
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. | Bio-Rad D-10TM Dual Program run on the D-10
Hemoglobin Testing System without
D-10 Rack Loader
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. |
| 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 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, 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 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 | Traceable to the Diabetes Control and
Complications Trial (DCCT) reference method and
IFCC. Certified via the National Glycohemoglobin
Standardization Program (NGSP) for HbA1c.
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 | Traceable to the Diabetes Control and Complications
Trial (DCCT) reference method and IFCC. Certified
via the National Glycohemoglobin Standardization
Program (NGSP) for HbA1c.
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, F and A1c | Quantitative Area % HbA2, F and A1c |
| Time to process sample | 6.5 minutes | 6.5 minutes |
:
:
6
D-10™ Dual Program (k)0414444
7
D-10™ Dual Program (k)0414444
.
| Summary of Technological Characteristic Differences in Comparison to Predicate Device | ||
|---|---|---|
| Characteristics | New Device: | |
| D-10TM Hemoglobin A1c Program run on the | ||
| D-10 Hemoglobin Testing System with | ||
| D-10 Rack Loader | Predicate Device: | |
| D-10TM Hemoglobin A1c Program run on the | ||
| D-10 Hemoglobin Testing System without the | ||
| D-10 Rack Loader | ||
| Software version | 3.5 | 3.00 |
| Number of Racks that | ||
| can be run. | 5 Racks of 10 EDTA whole blood tubes | 1 rack of 10 EDTA whole blood tubes |
| Rack insertion into | ||
| D-10 Hemoglobin | ||
| Testing System | Automated | Manual |
.
:
8
Testing To Establish Substantial Equivalence:
Note: The D-10 Hemoglobin Testing System currently contains one rack for 10 Note. The D-10 Hemoglobin Techanges. Throughout this decument the EDTA Will indicate either the D-10 Hemoglobin A1c Program or D-10 Dual Program text will mithout the D-10 Rack Loader on the D-10 Hemoglobin Testing are run. The D-10 Rack Loader is an optional accessory item to the D-10 System. The D-10 Rack Dodater 1. alows for 5 racks of 10 EDTA Whole Blood Tubes to be run automatically while the system is running in mid size laboratories.
Accuracy:
D-10 Hemoglobin HbA1c Program (3 minute)
Method correlation between Bio-Rad D-10 Hemoglobin AIc Program with D-10 Rack Loader Method Correlation betwoon Die naam without D-10 Rack Loader was evaluated using 40 EDTA and D-10 Hemogroom 1170 Frogram -14.3% HbA1c. The results are presented in the following table:
| D-10 Hemoglobin A1c Program Correlation for HbA1c | ||||
|---|---|---|---|---|
| Regression Method | n | r2 | Slope | Intercept |
| Least Squares | 40 | 0.9950 | 0.9415 | 0.2714 |
Householding A1e Drogram Correlation for HbA1c
D-10 Dual Program -Hemoglobin A1c (6.5 minute)
Method correlation between Bio-Rad D-10 Dual Program with D-10 Rack Loader and D-10 Dual Mothou correlated. 10 Rack was evaluated using 40 EDTA whole blood samples ranging from 5.1% to 14.3% HbA10. The results are presented in the following table:
D-10 Dual Program Correlation for HbA1c
| Regression Method | n | r2 | Slope | Intercept |
|---|---|---|---|---|
| Least Squares | 40 | 0.9956 | 0.9827 | 0.1208 |
D-10 Dual Program - Hemoglobin A2 (6.5 minute)
Method correlation between Bio-Rad D-10 Dual Program with D-10 Rack Loader and D-10 Dual Program without Rack Loader was evaluated with 39 EDTA whole blood samples ranging from 2.1% - 11.8% HbA2. The results are presented in the following table:
| D-10 Dual Program Correlation for HbA2 | ||||
|---|---|---|---|---|
| -- | ---------------------------------------- | -- | -- | -- |
| Regression Method | n | r2 | Slope | Intercept |
|---|---|---|---|---|
| Least Squares | 39 | 0.9975 | 0.9902 | 0.2476 |
D-10 Dual Program - Hemoglobin F (6.5 minute)
Method correlation between Bio-Rad D-10 Dual Program with D-10 Rack Loader and D-10 Dual Program without D-10 Rack Loader was evaluated with 39 EDTA whole blood samples ranging from 0.8% - 17.3% HbF. The results are presented in the following table:
| D-10 Dual Program Correlation for HBF | ||||
|---|---|---|---|---|
| Regression Method | n | r2 | Slope | Intercept |
| Least Squares | 39 | 0.9956 | 1.0188 | -0.3863 |
D 16TM Dual Program Correlation for HhF
Bio-Rad Laboratories, Inc.
9
Precision:
D-10 Hemoglobin A1c Program (3 minute)
The following precision table provides comparison data on the precision between D-10 Hemoglobin A 1c Program with the D-10 and Rack Loader and the D-10 Hemoglobin A Ic Program without the D-10 Rack Loader, each utilizing EDTA whole blood patient samples.
Method precision was performed using a protocol based on the NCCLS Evaluation protocol, EP5-A2 for the D-10 Hemoglobin A1c Program with D-10 Rack Loader and NCCLS Evaluation protocol EP5-T2 for the D-I0 Hemoglobin A1c Program without Rack Loader. The protocols for both the D-10 Hemoglobin A1c Program with D-10 Rack Loader and D-10 Hemoglobin A1c Programs without D-10 Rack Loader are similar. Using these protocols, two samples were run on one rack, twice a day over 20 working days on one D-10 Hemoglobin Testing System without D-10 Rack Loader. On the D-10 Hemoglobin Testing System with D-10 Rack Loader, the protocol requires two samples run on each of five racks, twice a day over 20 working days. In each duplicate daily run for both verification studies, duplicate aliquots of normal HbA 1c and diabetic HbAlc 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 Hemoglobin A1c Program with D-10 Rack Loader and the D-10 Hemoglobin A1c Program without D-10 Rack Loader are equivalent. A summary of combined comparative precision results is presented in the following precision table.
| D-10 HbA1c with D-10 Rack Loader vs. D-10 HbA1c without D-10 Rack Loader - | |
|---|---|
| Precision |
| D-10 HbA1c
with D-10 Rack Loader | | D-10 HbA1c
without D-10 Rack Loader | | |
|-------------------------------------|-----------------|----------------------------------------|-----------------|------|
| Normal Sample | Diabetic Sample | Normal Sample | Diabetic Sample | |
| n= (number of samples) | 400 | 400 | 80 | 80 |
| Mean (%HbA1c) | 5.6 | 11.0 | 5.9 | 13.1 |
| Within run (%CV) | 0.6 | 0.6 | 0.8 | 0.3 |
| Total Precision (%CV) | 1.5 | 1.4 | 1.8 | 0.9 |
D-10 Dual Program - HbA1c (6.5 minutes)
The following precision table provides comparison data on the precision between D-10 Dual Program (HbA1c) with Rack Loader and the D-10 Duq1 Program (HbA1c) without the D-10 Rack Loader, each utilizing EDTA whole blood patient samples.
Method precision was performed using a protocol based on the NCCLS Evaluation protocol EP5-A2 for the D-10 Dual Program with D-10 Rack Loader and NCCLS Evaluation protocol EPS-A for the D-10 Dual Program without Rack Loader. The protocols for both the D-1010 Dual Program with D-10 Rack Loader and D-10 Dual Program without D-10 Rack Loader are similar. Using these protocols, two samples were run on one rack, twice a day over 20 working days on one D-10 Hemoglobin Testing System. On the D-10 Hemoglobin Testing System with D-10 Rack Loader, the protocol requires two samples run on each of five racks, twice a day over 20 working days. In each duplicate daily run for both verification studies, duplicate aliquots of normal HbAL and diabetic HbA1c 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
Bio-Rad Laboratories, Inc.
10
Dual Program with D-10 Rack Loader and the D-10 Dual Program without D-10 Rack Loader are equivalent. A summary of combined comparative precision results is presented in the following precision table.
| | | D-10 Dual (6.5 Minutes)
HbA1c Program with D-10 Rack
Loader | | D-10 Dual (6.5 Minutes)
HbA1c Program without D-10
Rack Loader | |
|------------------------|--|-------------------------------------------------------------------|-----------------|----------------------------------------------------------------------|-----------------|
| | | Normal Sample | Diabetic Sample | Normal Sample | Diabetic Sample |
| n= (number of samples) | | 400 | 400 | 80 | 80 |
| Mean (%HbA1c) | | 5.5 | 10.6 | 5.9 | 13.1 |
| Within run (%CV) | | 0.7 | 0.4 | 0.8 | 0.3 |
| Total Precision (%CV) | | 1.5 | 1.2 | 1.8 | 0.9 |
D-10 Dual Program (HbA1c) with D-10 Rack Loader vs. D-10 Dual Program (HbA1c) without D-10 Rack Loader - Precision
D-10 Dual Program HbA2 (6.5 minutes)
The following precision table provides comparison data on the precision between D-10 Dual Program (HbA2) with D-10 Rack Loader and D-10 Dual Programs (HbA2) without D-10 Rack Loader, each utilizing EDTA whole blood patient samples.
Method precision was performed using a protocol based on the NCCLS Evaluation protocol EPS-A2 for the D-10 Dual Program with D-10 Rack Loader and NCCLS Evaluation protocol EP5-A for the D-10 Dual Program without Rack Loader. The protocols for both the D-10 Dual Program with D-10 Rack Loader and D-10 Dual Program without D-10 Rack Loader are similar. Using these protocols, two samples were run on one rack, twice a day 40 runs over 20 working days were performed on one D-10 Hemoglobin Testing System. On the D-10 Hemoglobin Testing System with D-10 Rack Loader, the protocol requires two samples run on each of five racks, twice a day over 20 working days. In each duplicate daily run for both verification studies, duplicate aliquots of low HbA2 and high HbA2 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 with D-10 Rack Loader and the D-10 Dual Program without D-10 Rack Loader 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 (HbA2) with D-10 Rack Loader vs. D-10 Dual Program (HbA2) without D-10 Rack Loader - Precision
| | D-10 Dual Program (6.5 Minutes)
HbA2 run with D-10 Rack Loader | | VARIANT II β-thalassemia Short
HbA2 run without D-10 Rack Loader | |
|------------------------|-------------------------------------------------------------------|-------------|---------------------------------------------------------------------|-------------|
| | Low Sample | High Sample | Low Sample | High Sample |
| n= (number of samples) | 400 | 400 | 80 | 80 |
| Mean (%HbA2) | 2.9 | 4.9 | 2.2 | 5.4 |
| Within run (%CV) | 1.8 | 1.2 | 4.5 | 1.7 |
| Total Precision (%CV) | 3.6 | 3.6 | 5.3 | 3.1 |
D-10 Dual Program -- HbF (6.5 minutes)
The following precision table provides comparison data on the precision between D-10 Dual Program (HbF) with the D-10 Rack Loader and the D-10 Dual Program (HbF) without D-10 Rack Loader, each utilizing EDTA whole blood patient samples.
Method precision was performed using a protocol based on the NCCLS Evaluation protocol EP5-A2 for the D-10 Dual Program with D-10 Rack Loader and NCCLS Evaluation protocol EP5-A for the D-10 Dual Program without Rack Loader. The protocols for both the D-10 Dual Program with D-10 Rack Loader and D-10 Dual Program without D-10 Rack Loader are similar. Using these protocols, two samples were run on one rack, twice a day over 20 working days on one D-10 Hemoglobin Testing System. On the D-10 Hemoglobin Testing System with D-10 Rack Loader, the protocol requires two samples run on each of five racks, twice a day over 20 working days. In each duplicate daily run for both verification studies, duplicate aliquots of low HbF and 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 with D-10 Rack Loader and the D-10 Dual Program without D-10 Rack Loader are equivalent. A summary of combined comparative precision results is presented in the following. precision table.
D-10 Dual Program (HbF) with D-10 Rack Loader vs. D-10 Dual Program (HbF) without D-10 Rack Loader - Precision
| | D-10 Dual Program (6.5 minutes)
HbF with D-10 Rack Loader | | D-10 Dual Program (6.5 minutes)
HbF without D-10 Rack Loader | |
|------------------------|--------------------------------------------------------------|-------------|-----------------------------------------------------------------|-------------|
| | Low Sample | High Sample | Low Sample | High Sample |
| n= (number of samples) | 400 | 400 | 80 | 80 |
| Mean (%HbF) | 1.4 | 6.6 | 2.1 | 8.7 |
| Within run (%CV) | 2.1 | 0.8 | 1.7 | 1.4 |
| Total Precision (%CV) | 2.9 | 1.8 | 3.3 | 2.0 |
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Conclusion:
The similarities of the intended use and the general performance characteristics and results of the rne shimarities of the mendou ass and and and gold in A1c Program and D-10 Dual Program with Ilowiy doser loca and brand be management Testing system are nearly identical to or logical D 10 Nack Louder on the two cleared predicate program systems [i.e., the Bio-Rad D-10 Hemoglobin Aie Program and the Bio-Rad Dual Program]. Thus, one may conclude, based on the use of the same HPLC technology, and the nearly equivalent results obtained for the the use of the same II 12 corresponding results obtained with the two predicate eoreanshall provision versas no obin A1c Program and D-10 Dual Program with D-10 Bystems the D-10 Hemoglobin Testing system is substantially equivalent to these 2 cleared and currently marketed predicate systems.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jackie Buckley Regulatory Affairs Representative Bio-Rad Laboratories, Inc. Clinical Systems Division 4000 Alfred Nobel Dr. Hercules, CA 94547
JAN 2 0 2006
K060001 Re:
Trade/Device Name: Bio-Rad D-10TM Dual Program and D-10 Hemoglobin A1c Program run on the D-10 Hemoglobin Testing System with D-10 Rack Loader Regulation Number: 21 CFR§864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JPD Dated: December 30, 2005 Received: January 3, 2006
Dear: Ms. Buckley:
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 commerce prior 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 can be found in Title 21, Code 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small 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/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
15
Indications for Use
510(k) Number (if known): K060001
Bio-Rad D-10™ Dual Program and D-10 Hemoglobin A1c Device Name: Program run on the D-10 Hemoglobin Testing System with D-10 Rack Loader Measurements of percent HbA1c are effective in monitoring Indications For Use: long-term glucose control in individuals with diabetes mellitus. Measurement of percent HbA2 and HbF are used for evaluation ß - thalassemia, a hereditary hemolytic anemia. Detection of hemoglobin variants such as S, C, D and E are effective in presumptive identification.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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)
Ann Chopper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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