(263 days)
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No
The description details a chemical assay and measurement process based on absorbance and turbidimetry, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic product intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. It is used to measure long-term glucose control in patients with diabetes mellitus, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states: "Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus." This indicates its use in evaluating a medical condition. While the text specifies "The absolute HbA1c and Total Hemoglobin (THb) values generated... must be not used individually for diagnostic purposes," it clarifies that the ratio (HbA1c/Total Hemoglobin) is the intended diagnostic output. Furthermore, it explicitly mentions "For In Vitro Diagnostic Use only," confirming its diagnostic purpose.
No
The device description clearly outlines the use of chemical reagents and a colorimetric/turbidimetric method involving absorbance measurements, indicating a hardware-based in vitro diagnostic device, not software only.
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 only."
- Purpose: The device is intended for the "quantitative determination of hemoglobin A1c concentration in human whole blood." This is a measurement performed on a biological sample (whole blood) outside of the body (in vitro) to provide information for diagnostic purposes related to diabetes mellitus.
- Components: The description details reagents and calibrators specifically designed for this in vitro test.
- Clinical Relevance: The measurement of hemoglobin A1c is explicitly stated as a method to "measure long-term glucose control in patients with diabetes mellitus," highlighting its diagnostic relevance.
N/A
Intended Use / Indications for Use
The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only.
The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must be not used individually for diagnostic purposes.
The HbA1c Calibrators is an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems.
Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JIT
Device Description
The HbA1c assay (B00389) involves the use of four reagents: Total Hemoglobin R1, HbA1c R1, HbA1c R2, and Hemolyzing Reagent (sold separately as Cat. No. 472137). In a pre-treatment step, whole blood is mixed with the Hemolyzing Reagent in a 1 to 100 dilution and the resultant hemolysate is used. Tetradecyltrimethylammonium bromide (TTAB) in the Hemolyzing Reagent eliminates interference from leukocytes. The concentrations of both HbA1c and Total Hemoglobin are determined. The HbA1c/Total Hemoglobin ratio is expressed either as mmol/mol (IFCC) or %HbA1c (DCCT/NGSP). Total Hemoglobin Reagent is used to measure total hemoglobin concentration by a colorimetric method. Change is absorbance is measured at 570/660 nm. HbA1c reagent is used to measure hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, hemoglobin A1c antibodies combine with HbA1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. Change in absorbance is measured at 340/700 nm.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study Results:
- Candidate: AU HbA1c Test System
- Slope: 0.901
- Intercept: 0.3140
- R: 0.9941
- N: 130
- Predicate Method: SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent
AU HbA1c Test System Precision Study Results:
- Within run imprecision:
- Sample Type: Hemolysate Control Pool 1, No. of Data Points: 80, Mean %HbA1c: 5.3, CV%: 1.44, SD (%HbA1c): 0.08
- Sample Type: Hemolysate Control Pool 2, No. of Data Points: 80, Mean %HbA1c: 7.4, CV%: 1.03, SD (%HbA1c): 0.08
- Sample Type: Hemolysate Control Pool 3, No. of Data Points: 80, Mean %HbA1c: 9.4, CV%: 1.03, SD (%HbA1c): 0.10
- Total imprecision:
- Sample Type: Hemolysate Control Pool 1, No. of Data Points: 80, Mean %HbA1c: 5.3, CV%: 2.07, SD (%HbA1c): 0.11
- Sample Type: Hemolysate Control Pool 2, No. of Data Points: 80, Mean %HbA1c: 7.4, CV%: 1.84, SD (%HbA1c): 0.14
- Sample Type: Hemolysate Control Pool 3, No. of Data Points: 80, Mean %HbA1c: 9.4, CV%: 1.68, SD (%HbA1c): 0.16
Based on the performance testing the AU® Systems HbA1c (Hemoglobin) Test System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
THb:
LoB = 0.05 mmol/L (0.09 g/dL);
LoD = 0.10 mmol/L (0.16 g/dL).
HbA1c:
LoB = 0.12 mmol/L (0.19 g/dL);
LoD = 0.13 mmol/L (0.22 g/dL).
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
OCT 1 2 2012
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved white lines inside, placed to the left of the company name. The text "BECKMAN" is stacked on top of "COULTER" in a bold, sans-serif font.
510k Summary AU® Systems HbA1c (Hemoglobin) Test System
1.0 Submitted By:
Bev Harding Sr. Regulatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 Telephone: 972-831-3656 Fax: 972-831-3684 Email: bbharding@beckman.com
2.0 Date Submitted:
January 20, 2012
3.0 Device Name(s):
3.1 Proprietary Names AU® Systems HbA1c (Hemoglobin) Test System
3.2 Classification Name
Glycosylated hemoglobin assay (21 CFR § 864.7470)
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|--------------------------------------------------|-------------------------------------------------------|-------------------------|------------------|
| AU® Systems HbA1c
(Hemoglobin) Test
System | SYNCHRON Systems
Hemoglobin A1c
(HbA1c) Reagent | Beckman
Coulter, Inc | K010748 |
5.0 Description:
The HbA1c assay (B00389) involves the use of four reagents: Total Hemoglobin R1, HbA1c R1, HbA1c R2, and Hemolyzing Reagent (sold separately as Cat. No. 472137). In a pre-treatment step, whole blood is mixed with the Hemolyzing Reagent in a 1 to 100 dilution and the resultant hemolysate is used. Tetradecyltrimethylammonium bromide (TTAB) in the Hemolyzing Reagent eliminates interference from leukocytes.
1
The concentrations of both HbA1c and Total Hemoglobin are determined. The HbA1c/Total Hemoglobin ratio is expressed either as mmol/mol (IFCC) or %HbA1c (DCCT/NGSP). Total Hemoglobin Reagent is used to measure total hemoglobin concentration by a colorimetric method. Change is absorbance is measured at 570/660 nm. HbA1c reagent is used to measure hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, hemoglobin A1c antibodies combine with HbA1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. Change in absorbance is measured at 340/700 nm.
6.0 Intended Use:
The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only.
The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must not be used individually for diagnostic purposes.
The HbA1c Calibrators are an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems.
Measurement of hemoglobin A1c is accepted as a method to measure longterm glucose control in patients with diabetes mellitus.
Clinical Significance:
Measurement of hemoglobin A1c is accepted as a method to measure longterm glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin A1c provides an important tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus. Long term treatment of the disease emphasizes control of blood glucose levels in preventing the acute complications of ketosis and hyperglycemia. In addition, long term complications such as retinopathy, neuropathy, and cardiovascular disease can be minimized if blood glucose levels are effectively controlled.
The process of conversion from hemoglobin A to hemoglobin A1c depends on the blood glucose concentration. Since the average life of a red blood cell is 120 days, measurement of hemoglobin A1c can reflect the mean daily blood glucose concentration over the preceding two to three months and provides a much better indication of glycemic control than blood or urinary glucose determinations.
2
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary.
| Feature | Predicate Device:
K010748 | New Device: | Similarities |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The hemoglobin a1c
reagent kit, when used in
conjunction with
SYNCHRON LX®
System(s), UniCel® DxC
600/800 System(s),
SYNCHRON® Systems
HbA1c Calibrators and
SYNCHRON® Systems
Hemolyzing Reagent, is
intended for the
quantitative
determination of
hemoglobin a1c
concentration as a
percentage of total
hemoglobin in human
wholeblood. | The HbA1c (Hemoglobin
A1c) reagent, when used
in conjunction with
Beckman Coulter
Systems, HbA1c
Calibrators and
SYNCHRON and AU
Hemolyzing Reagent, is
intended for the
quantitative
determination of
hemoglobin A1c
concentration in human
whole blood. For in vitro
diagnostic use only.
The absolute HbA1c and
Total Hemoglobin (THb)
values generated as part
of the HbA1c assay are
intended for use in the
calculation of the
HbA1c/Total Hemoglobin
ratio and must not be used
individually for diagnostic
purposes. | Similar |
| Technology | Colorimetric | Colorimetric | Same |
| Methodology | Turbidimetric
immunoinhibition | Turbidimetric
immunoinhibition | Same |
| Specimen Type | Whole blood | Whole blood | Same |
| Packaging | Reagents and calibrators
in kit; Hemolyzing
reagent sold separately. | Reagents and calibrators
in kit; Hemolyzing
reagent sold separately. | Similar |
| Sample Type | Freshly drawn blood
treated with EDTA or
heparin is the preferred
specimen. Details on
EDTA. Lithium Heparin,
and Sodium heparin are
in IFU. | K2-EDTA, K3-EDTA, Li-
Heparin or Na-Heparin
whole blood (freshly
drawn blood treated with
EDTA is the preferred
specimen). | Similar |
| Sample
Preparation | Before use, pre-treat
samples by manual | Before use, pre-treat
samples and controls by | Similar |
| | dilution. | manual dilution. | |
| Reagent Format
and Storage | Liquid Stable
2 - 8°C | Liquid Stable
2 - 8°C | Similar |
| Calibrator matrix
base | Hemolysate (human and sheep) | Hemolysate (human and sheep) | Same |
| Traceability | IFCC HbA1c Reference
Method. Process based
on prEN ISO 17511.
Data is converted to
NGSP units via the use
of the Master Equation. | IFCC HbA1c Reference
Method. Data is
converted to NGSP units
via the use of the Master
Equation. | Similar |
| Certification | NGSP certified | NGSP certified | Similar |
| Reference
Interval | Literature 4.0 - 6.0%
HbA1c
SYNCHRON 4.6-2.6%
HbA1c | 4.0 - 6.0% HbA1c | Performance
data within the
submission
supports
substantial
equivalence and
reference
interval. |
| Interfering
Substances | No significant
interference (within ±
0.80% HbA1c or 10%)
Bilirubin (unconjugated)
30 mg/dL
Lipemia 400 mg/dL
RF 3000 IU/ml
Ascorbic acid 50 mg/dL
Labile glycated
hemoglobin ≤10% up to
1000 mg/dL (5 hours at
37°C)
Cross reactivity and Hb
Variants interference
data also presented in
IFU. | Bilirubin ≤6% up to 30
mg/dL
Lipemia ≤6% up to 400
mg/dL Intralipid®
RF ≤6% up to 1000
IU/mL
Ascorbic Acid ≤6% up to
50 mg/dL
Labile glycated
hemoglobin ≤10% up to
2000 mg/dL (5 hours at
37°C)
Cross reactivity and Hb
Variants interference
data also presented in
IFU | Similar |
| Feature | Predicate Device: | New Device: | Differences |
| Precision | Within 5.0%
Total 7.5 % | Within 4.0%
Total 4.0% | Different
Performance data within the
submission supports
improved precision and
substantial equivalence of
the new test system. |
| Analytical
Measuring Range | 2 - 20% HbA1c | 4 - 15% HbA1c
(NGSP)/20 - 140
mmol/mol (IFCC) | Different
NGSP units are
reported as
%HbA1c; IFCC
units are
reported as
mmol/mol.
Method
comparison and
linearity data
helped support
extending the
range on the AU
HbA1c. |
| Instrument | SYNCHRON LX®
System(s), UniCel® DxC
600/800 System(s),
SYNCHRON® Systems | Models of AU analyzers | Different
The AU analyzer
data within the
submission
supports the
substantial
equivalence for
AU480, AU680
and the AU2700
Beckman
Coulter
Analyzers. |
| Calibrator Format
and Levels | Lyophilized
5 levels
Hb = single point
A1c = multi point | Lyophilized
5 levels
THb = two point
HbA1c = multi point | Different
The number of
calibrators used
is method-
specific.
Performance
data within the |
| | | | |
| Pre-treatment
Reagent | SYCHRON Hemolyzing
Reagent
1000 μL hemolyzing
reagent in test tube
Add exactly 10 μL of
whole blood sample | SYCHRON and AU
Hemolyzing Reagent
Ratio 1 to 100 dilution
Pre-treatment - until
hemolysis is complete
(approx. 1-2 minutes). | submission
supports
substantial
equivalence of
the calibrators
and new
reagents.
Different
Performance
data within the
submission
supports
substantial
equivalence. |
| Stability | Calibrator & Reagent
unopened store at 2° to
8°C until expiration date
Calibrator reconstituted =
8 hours 15°- 25°C
48 hours at 2°- 8°C
unless expiration date is
exceeded
Open hemoglobin
reagent stable 60 days at
2°-8°C unless exp. date
exceeded.
Open A1c reagent stable
30 days at 2°- 8°C
unless exp. date
exceeded. | Calibrator & Reagent
unopened store at 2° to
8°C until expiration date
Calibrator reconstituted =
up to 8 hours at 15 -
25°C
up to 30 hours at 2 - 8°C
up to 30 days at - 20 °C.
Calibration Stability = 14
days
Reagent on-board = 30
days
Kit Shelf Life Stability =
18 months at launch | Different
Stability data
within the
submission
supports new
claims. |
| Reporting Units | SYNCHRON calculations
IFCC HbA1c
concentration in percent.
Must use calculation in
IFU that converts IFCC to
NGSP. | % HbA1c (NGSP) and
mmol/mol (IFCC) | Different
IFCC /IUPAC
committee
updated their
recommend-
ations on HbA1c
units and
nomenclature in
2007. |
| Sensitivity | Sensitivity is defined as
the lowest measurable
concentration which can
be distinguished from | THb:
LoB = 0.05 mmol/L (0.09
g/dL);
LoD = 0.10 mmol/L (0.16
g/dL) | Different
Sensitivity for
the new device |
| | | | |
| | zero with 95%
confidence.
Sensitivity for the total
hemoglobin
determination is 6 g/dL.
Sensitivity for the A1c
determination is 0.3 g/dL. | g/dL).
HbA1c:
LoB = 0.12 mmol/L (0.19 g/dL);
LoD = 0.13 mmol/L (0.22 g/dL). | refers to LoB
and LoD, rather
than general sensitivity.
Performance
data within the
submission
supports
substantial
equivalence and
new claim. |
| Specimen
Storage and
Stability | Whole blood samples
stable for:
No longer than 7 days at
2 - 8°C
3 months at -15 C to -
20°C
Hemolysate stable 4
hours at room
temperature and 24
hours at 2° to 8°C | Samples (non-pretreated)
are stable up to 8 hours
when stored at 25°C,
7 days when stored at
2...8°C and up to 3
months when frozen at -
20°C. Whole blood
samples are stable for 18
months at -70°C
Hemolyzed (pre-treated)
samples are stable up to
4 hours when stored at
15...25°C, up to 24 hours
when stored at 2...8°C, if
stored in a sealed
container. | Different
Stability data
within the
submission
supports
substantial
equivalence and
new claims. |
Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
Telephone: (714) 993-53321
Facsimile: (714) 961-4234
Internet: www.beckmancoulter.com
3
Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
.
.
Telephone: (714) 993-5321
Facsimile: (714) 961-4234
Internet: (714) 961-4234
Internet: www.beckmancoulter.com
・
,
4
Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
.
.
5
.
Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
Telephone: (714) 993-5321
Facsimile: (714) 961-4234
Internet: www.beckmancoulter.com
6
8.0 Summary of Performance Data:
Based on the performance testing the AU® Systems HbA1c (Hemoglobin) Test System is substantially equivalent to the predicate device.
7
Method Comparison Study Results
·
| Candidate | Slope | Intercept | R | N | Predicate
Method |
|-------------------------|-------|-----------|--------|-----|-------------------------------------------------------------|
| AU HbA1c Test
System | 0.901 | 0.3140 | 0.9941 | 130 | SYNCHRON
Systems
Hemoglobin A1c
(HbA1c)
Reagent |
AU HbA1c Test System Precision Study Results
| TYPE OF
IMPRECISION | SAMPLE TYPE | No. of
Data
Points | Mean
%HbA1c | CV% | SD
(%HbA1c) |
|------------------------|------------------------------|--------------------------|----------------|------|----------------|
| Within run | Hemolysate
Control Pool 1 | 80 | 5.3 | 1.44 | 0.08 |
| | Hemolysate
Control Pool 2 | 80 | 7.4 | 1.03 | 0.08 |
| | Hemolysate
Control Pool 3 | 80 | 9.4 | 1.03 | 0.10 |
| Total | Hemolysate
Control Pool 1 | 80 | 5.3 | 2.07 | 0.11 |
| | Hemolysate
Control Pool 2 | 80 | 7.4 | 1.84 | 0.14 |
| | Hemolysate
Control Pool 3 | 80 | 9.4 | 1.68 | 0.16 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract bird or wing-like design. The seal is black and white and appears to be a logo or official symbol.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Beckman Coulter, Inc c/o Beverly Harding 250 S. Kraemer Blvd. Mail Stop A2 SW.08 Brea, California 92821
Re: K120199
Trade Name: AU® Systems HbA1c (Hemoglobin A1c) Test System Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Codes: LCP, JIT Dated: September 11, 2012 Received: September 13, 2012
Dear Ms. Harding:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
OCT
12 2012
9
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Devices and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, prouse meter to regarding postmarket surveillance, please contact CDRH S Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
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) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
f
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
10
Indication for Use
510(k) Number (if known): K 12019 9
Device Name: AU® Systems HbA1c (Hemoglobin A1c) Test System
Indication For Use:
The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only.
The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must be not used individually for diagnostic purposes.
The HbA1c Calibrators is an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems.
Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus.
Prescription Use _ X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Rattin Sussa
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 120199