The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.

AI/ML Overview

The provided text describes a 510(k) summary for the Quantimetrix GlycoHemosure, a quality control material for HbA1c quantitation. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a medical device that makes diagnostic claims (e.g., sensitivity, specificity, accuracy).

Instead, the documentation focuses on the stability of the control material, which is a key performance characteristic for a quality control device.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Text)	Reported Device Performance
Shelf Life (2-8°C): Control material must maintain stability for a specified period.	At least 18 months shelf life (2-8°C).
Opened Vial Stability: Control material must maintain stability for a specified period after opening.	At least 30 days opened vial stability.

Note: The text explicitly mentions "stability studies" were performed to "validate the shelf life claim and the opened vial claim." This implies that the acceptance criteria for these claims would be met if the control material remained within acceptable analytical ranges over these timeframes. However, the specific numerical acceptance limits (e.g., ±X% variation from initial value) are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The text states "Accelerated stability studies (25°C and 37°C) and real time studies (2-8°C) were performed."

Sample Size: Not specified. This typically refers to the number of vials or batches tested.
Data Provenance: Not specified, but implies internal testing by Quantimetrix Corporation. It is prospective testing for stability.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a control material, not a diagnostic device that requires expert interpretation for its "ground truth." Its performance relates to its internal stability and consistency over time, measured against a reference method.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for the performance of a quality control material in this context. The "truth" for its stability is determined by analytical measurements against a defined reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not relevant for a quality control material. MRMC studies are designed for diagnostic devices where human readers interpret results, and the study assesses how the device aids human performance.

6. Standalone Performance

Yes, implicitly. The stability studies evaluate the performance of the GlycoHemosure control material itself, without human interpretation or intervention beyond conducting the analytical measurements. The device's "performance" here is its inherent stability over time when measured using a standard HbA1c immunoassay.

7. Type of Ground Truth Used

The ground truth for the GlycoHemosure's stability is established by analytical measurement against a reference method or baseline value. The initial HbA1c concentration of the control material was determined using an immunoassay method (e.g., Dade HbA1c assay), and stability is assessed by comparing subsequent measurements to this initial value (or a derived reference) over time under different conditions.

8. Sample Size for the Training Set

Not applicable. Quality control materials fundamentally operate differently from AI/ML algorithms which require training sets. The GlycoHemosure is a prepared biological material with known concentrations, not an algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device. The quality control material itself serves as a "known" for laboratories to check the performance of their own HbA1c assays. Its own characteristics (concentration, stability) are established through analytical testing and manufacturing specifications.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Quantimetrix Corporation, along with their address at 2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278-1205. The logo features the letters 'QC' in a stylized, overlapping design. Above the logo is the date 'OCT 30', likely indicating a document or event date.

(800) 624-8380 or (310) 536 1800) 845-1834 or Bi0153

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is:

Proprietary Name:Common Name:Classification Name:Medical specialty:Product Code:Device class:Regulation No:Manufacturer:	GlycoHemosureCalibrators/ControlsGlycosylated Hemoglobin AssayHematologyLCP2864.7470Quantimetrix Corporation2005 Manhattan Beach BoulevardRedondo Beach CA 90278Phone: 310/536-0006 FAX: 310/536-9977
Contact Persons:	Gebhard Neyer, Ph.D., Director of R&D, 310-536-0006
Registration No:	2020715

The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.

The HbA1c concentration was determined using an immunoassay method, e.g. Dade HbA1c assay.

The Quantimetrix control material is substantially equivalent to the currently marketed

Lyphochek Diabetes Control manufactured by Bio-Rad Laboratories.

Both feature similar matrices, constituents and stability claims.

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Intended Use

The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.

Performance Characteristics

Accelerated stability studies (25°C and 37°C) and real time studies (2-8°C) were performed to validate the shelf life claim and the opened vial claim of the control material. The results support a shelf life claim (2-8°C) of at least 18 months and an opened vial claim of at least 30 days.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three birds in flight, arranged in a diagonal line. The birds are depicted with simple, curved lines, giving them a sense of movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

OCT 3 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Gebhard Neyer Director. Research & Development Quantimetrix Corp 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278-1205

Re: K032791

Trade/Device Name: GlycoHemosure Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GGM Dated: September 1, 2003 Received: September 15, 2003

Dear Dr. Neyer:

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 vour 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 Butman

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): KO3X79/

Device Name:

GlycoHemosure

Indications For Use:

The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.

Carol C. Benson R. Jean Cooper. DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03 2791

O R

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.