HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL by THERMO ELECTRON OY

The hemoglobin A1c (HbA1c) test system with associated calibrators and controls is intended for quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "HbA1c Test System, Calibrator, Control normal, and Control abnormal." It primarily discusses the regulatory approval process and does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria.

Therefore, most of the requested information cannot be extracted from this document as it focuses on regulatory clearance rather than a detailed technical performance study.

Here's what can be inferred or stated based on the provided text:

Device Name: HbA1c Test System, HbA1c Calibrators, HbA1c Control Normal, HbA1c Control Abnormal
Intended Use: Quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Regulatory Status: Substantially equivalent to legally marketed predicate devices, Class II.

Regarding the specific questions about acceptance criteria and study details:

A table of acceptance criteria and the reported device performance: Not provided in the document. This type of information would typically be in the 510(k) submission itself (which is not this letter) and would detail performance metrics like accuracy, precision, linearity, and analytical measurement range, along with the criteria for acceptable performance (e.g., %CV < X, bias < Y%).
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For IVD devices like this HbA1c test, "ground truth" is typically established by comparative methods using a reference laboratory method or a highly accurate, established method, not individual expert readers.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for an IVD test's analytical performance evaluation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an In Vitro Diagnostic (IVD) device, not an imaging AI diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone test system (T60 Clinical Chemistry Analyzers with the HbA1c reagents). Its performance is inherently standalone in that the instrument processes the sample and provides a result. There isn't typically a "human-in-the-loop" performance of the algorithm in the same way an AI imaging tool would have. The interpreting physician uses the result.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For HbA1c tests, ground truth would typically be established by a reference method (e.g., HPLC or mass spectrometry-based methods) or by comparison to another FDA-cleared HbA1c method. The document does not specify which was used.
The sample size for the training set: Not applicable for this type of IVD chemical analyzer. There isn't a "training set" in the context of machine learning algorithms for this device. The system is calibrated using calibrators, and its performance is validated.
How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory approval letter and does not contain the detailed technical study information requested. Such details would be found within the 510(k) submission itself, in sections describing analytical performance validation studies.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. (USA)" is arranged in a circular fashion around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Päivi Sormunen Thermo Electron Oy Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland

MAR 2 1 2007

Re: K063209 Trade Name: HbA1c Test System, Calibrator, Control normal, and Control abnormal Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, KRZ, JJX Dated: February 07, 2007 Received: March 09, 2007

Dear Mr. Sormunen:

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).

{1}------------------------------------------------

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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): _ K063209

Device Name: HbA1c Test System, HbA1c Calibrators, HbA1c Control Normal, HbA1c Control Abnormal

Indications For Use:

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

K063209

Regulation Number and Section

§ 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).