(216 days)
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No
The summary describes a reagent kit and a chemistry system for quantitative determination of Hemoglobin A1C. The performance studies focus on standard analytical chemistry metrics like linearity, precision, and method comparison. There is no mention of AI, ML, or any computational methods beyond basic calculation.
No.
The device is an in-vitro diagnostic (IVD) reagent kit used to measure Hemoglobin A1C levels, which assess a patient's diabetes control. It does not directly provide therapy.
Yes
The device quantitatively determines Hemoglobin A1C results which are used to assess the level of control of a patient's diabetes, explicitly stating its role in monitoring glycemic control in diabetic patients. This makes it a diagnostic device as it aids in the diagnosis and monitoring of a medical condition.
No
The device is a reagent kit intended for use with a chemistry system, indicating it is a physical component used in a laboratory setting, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Hemoglobin A1C results are used to assess the level of control of a patient's diabetes." This is a diagnostic purpose performed on a biological sample (whole blood).
- Device Description: The description confirms it's for the "quantitative determination of HemoglobinA1C in whole blood" and that the results are "used in monitoring glycemic control in diabetic patients." This further reinforces its diagnostic nature.
- Sample Type: The device uses whole blood, which is a biological specimen.
- Setting: It's intended for use by "trained personnel in a professional setting," which is typical for IVD devices.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This description perfectly aligns with the ATAC Hemoglobin A1C Reagent Kit.
N/A
Intended Use / Indications for Use
The ATAC HemoglobinA1C Reagent Kit is intended for the quantitative determination of HemoglobinA1C in whole blood. HemoglobinA1Cresults are used in monitoring glycemic control in diabetic patients. The assay determines total hemoglobin and umole A1C. These values are then used in the calculation of %Hemoglobin A1C reagent is substantially equivalent to the Bayer HemoglobinA1C reagent, Bayer product no. T01-3639-01, cuttently marketed by Bayer Corporation, Tarrytown, New York.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
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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
whole blood
Indicated Patient Age Range
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Intended User / Care Setting
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
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)
The effectiveness of the ATAC HemoglobinA1C Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
Analyzing A1C calibrators run as unknowns validated Bayer linearity claims. Total hemoglobin linearity was validated using hemolysates that spanned the range of zero to 23 g/dL.
Precision is demonstrated by the replicate assay of Bayer DCA 2000 Controls and a pooled patient sample. Precision statistics, calculated analogous to the methods described in NCCLS Guideline EP-6P, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Control 1 | 32 | 5.581 | 0.189 | 3.38 | 0.265 | 4.74 |
| Control 2 | 31 | 10.345 | 0.254 | 2.46 | 0.318 | 3.08 |
| Patient | 31 | 6.777 | 0.176 | 2.60 | 0.316 | 4.66 |
Whole blood samples collected from patients and were assayed using the ATAC 8000 Random Access Chemistry System and by TOSOH HPLC method. Results were compared by least squares linear regression and the following statistics were obtained.
ATAC 8000 = 0.6367 + 0.9722 x Comparative Method
The 12 day calibration stability claim and 10 day on board stability claim are documented through the assay of controls and a pooled patient sample over the claimed periods. In all cases, the total imprecision of %HemoglobinA1C recoveries over the test periods are less than 5%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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NOV - 3 2003
October 30, 2003
Device Name:
ATAC HemoglobinA1C Reagent
Summary of 510(k) Safety and Effectiveness Information
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 ATAC HemoglobinAlC Reagent Kit is intended for the quantitative determination of HemoglobinA1C in whole blood. HemoglobinA1Cresults are used in monitoring glycemic control in diabetic patients. The assay determines total hemoglobin and umole A1C. These values are then used in the calculation of %Hemoglobin A1C reagent is substantially equivalent to the Bayer HemoglobinA1C reagent, Bayer product no. T01-3639-01, cuttently marketed by Bayer Corporation, Tarrytown, New York.
The effectiveness of the ATAC HemoglobinA1C Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
Analyzing A1C calibrators run as unknowns validated Bayer linearity claims. Total hemoglobin linearity was validated using hemolysates that spanned the range of zero to 23 g/dL.
Precision is demonstrated by the replicate assay of Bayer DCA 2000 Controls and a pooled patient sample. Precision statistics, calculated analogous to the methods described in NCCLS Guideline EP-6P, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Control 1 | 32 | 5.581 | 0.189 | 3.38 | 0.265 | 4.74 |
| Control 2 | 31 | 10.345 | 0.254 | 2.46 | 0.318 | 3.08 |
| Patient | 31 | 6.777 | 0.176 | 2.60 | 0.316 | 4.66 |
Whole blood samples collected from patients and were assayed using the ATAC 8000 Random Access Chemistry System and by TOSOH HPLC method. Results were compared by least squares linear regression and the following statistics were obtained.
ATAC 8000 = 0.6367 + 0.9722 x Comparative Method
The 12 day calibration stability claim and 10 day on board stability claim are documented through the assay of controls and a pooled patient sample over the claimed periods. In all cases, the total imprecision of %HemoglobinA1C recoveries over the test periods are less than 5%.
Wymun Strahn
Wynn Stocking
Manager, Regulatory Affairs
Clinical Data, Inc.
Brea, California
714-672-3553
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 3 2003
Mr. Wynn Stocking Manager, Regulatory Affairs Clinical Data, Inc. 1075 W. Lambert Road Building D Brea, CA 92821
Re: K031042
Trade/Device Name: ATAC HemoglobinA1C Reagent Regulation Number: 21 CFR 864. 7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: August 6, 2003 Received: August 7, 2003
Dear Mr. Stocking:
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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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K031042
Device Name:
ATAC Hemoglobin A 1C Reagent
Indications for Use:
The ATAC Hemoglobin A1C Reagent Kit is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of Hemoglobin A1C results are used to assess the level of control of a patient's diabetes.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (PDE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Carol C. Benam for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K03/042