Hemoglobin Alc Linearity is intended for use as quality control material to demonstrate linearity throughout the reportable range of Hemoglobin A1c (HbA1c%) for Immunoassay and HPLC test methods using protocols established in individual laboratories.

Device Description

The HbAIc Linearity Set is prepared from human blood to which stabilizers are added. The control is provided in liquid form for user convenience.

AI/ML Overview

This submission describes a medical device, the Cone Bioproducts' HbA1c Linearity Set, which is a quality control material. As such, the concept of "acceptance criteria" and "device performance" in the context of clinical efficacy (as with an AI diagnostic tool) does not directly apply. The submission focuses on demonstrating substantial equivalence to a predicate device for its intended use as a quality control material to verify linearity for HbA1c testing.

Therefore, many of the requested items (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not relevant to this type of device and its regulatory submission.

Instead, the "acceptance criteria" here are implicitly defined by the demonstration of substantial equivalence to the predicate device, LiniCAL Enzyme Calibration Verifiers (K040535), based on comparison of intended use and physical properties.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

As this is a quality control material seeking substantial equivalence, the "acceptance criteria" are not based on diagnostic performance metrics but rather on characteristics that establish its equivalence to a predicate. The "reported device performance" is essentially the detailed description of the subject device's characteristics compared to the predicate.

Characteristic	Acceptance Criteria (Implicitly from Predicate)	Reported Device Performance (Subject Device)
Intended Use	Quality control material to verify calibration/linearity of laboratory assays.	Hemoglobin A1c Linearity is intended for use as quality control material to demonstrate linearity throughout the reportable range of Hemoglobin A1c (HbA1c%) for Immunoassay and HPLC test methods.
Analyte	Multiple analytes (Alkaline Phosphatase, Alanine Aminotransferase, etc.)	Single Constituent: HbA1c
Methodology/ Analyzers	Beckman Coulter Synchron	Compatible with Immunoassay and HPLC HbA1c test methods.
Matrix	Human and Bovine Serum	Human Blood
Control Form	Liquid	Liquid
Levels	5 levels (A-E)	4 levels (1-4)
Storage	2°C to 8°C	-20°C
Unopened Vial Stability	3 Years (at 2-8°C)	2 Years (at -20°C)
Opened Vial Stability	14 days (at 2-8°C)	14 days (at 2-8°C)

Notes on the table: The "acceptance criteria" column is derived from the characteristics of the predicate device. The submission argues that even with differences (e.g., single vs. multiple analytes, specific methodologies), the subject device is substantially equivalent for its stated intended use (HbA1c linearity) as a quality control material.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided in the submission. The submission is for a quality control material, not a diagnostic or screening device that would typically involve a "test set" of patient data. The demonstration of equivalence relies on comparing product characteristics and intended use, not on a clinical performance study using patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the submission. There is no "test set" or "ground truth" establishment in the context of clinical interpretation by experts for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the submission. There is no "test set" requiring expert adjudication.

5. 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

This information is not applicable and not provided in the submission. This is a quality control material, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided in the submission. This is a quality control material, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable and not provided in the submission. For a quality control material, the "truth" is established by the known concentration or characteristic of the control material itself, and its ability to demonstrate linearity is assessed through its performance on a laboratory analyzer, not by comparison to external clinical ground truth.

8. The sample size for the training set

This information is not applicable and not provided in the submission. The device is a manufactured product (quality control material), not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided in the submission. As above, there is no "training set" for this type of device.

Summary

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

OCT 4 - 2005

SECTION II

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.

510(k) Number: K052010

Submitter:

Cone Bioproducts 1008 N. River Street Seguin, TX 78155

Telephone: (830)379-0197 Facsimile: (830)379-0471

Contact Person:

William K. Cone Regulatory Affairs Officer Telephone: (830)379-0197 ext. 203 Facsimile: (839)379-0471

Preparation Date:

September 1, 2005

Device Information:

Proprietary Name: Regulation Number: Regulatory Name: Product Code: Regulatory Class:

HbA1c Linearity Set 21 CFR8862.1660 Quality Control Material (assayed and unassayed) JJX Class I

Predicate Devices:

The HbA1c Linearity Set is substantially equivalent to LiniCAL Enzyme Calibration Verifiers (K040535) for its stated intended use.

Device Description:

The HbAIc Linearity Set is prepared from human blood to which stabilizers are added. The control is provided in liquid form for user convenience.

Intended Use:

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

Comparison to Predicate Device(s):

Cone Bioproducts' HbA1c Linearity Set is substantially equivalent to LiniCAL Enzyme Calibration Verifiers (K040535) for its stated intended use.

DeviceCharacteristics	Subject DeviceHemoglobin A1c Linearity Set	Predicate Device(s)LiniCAL Enzyme CalibrationVerifiers (K040535)
Intended Use	Hemoglobin A1c Linearity is intendedfor use as quality control material todemonstrate the linearity ofHemoglobin A1c (HbA1c%) forImmunoassay and HPLC test methodsusing protocols established inindividual laboratories.	LiniCAL Enzyme CalibrationVerifiers are intended for use in theclinical laboratory to verifycalibration and/or linearity of theBeckman Coulter Synchron ProteinSystems. Five assayed levels ofAlkaline Phosphatase, AlanineAminotransferase, Amylase, AsparateAminotransferase, Cholinesterase,Creatine Kinase, Creatine Kinase MB,Lactate Dehydrogenase, Lipase,Gamma Glutamyl Transferase, andPancreatic Amylase are provided toallow monitoring of the reportablerange.
Analyte	Single Constituent :A1c	Multiple Constituents:Alkaline Phosphatase, AlanineAminotransferase, Amylase, AsparateAminotransferase, Cholinesterase,Creatine Kinase, Creatine Kinase MB,Lactate Dehydrogenase, Lipase,Gamma Glutamyl Transferase, andPancreatic Amylase
Methodology/Analyzers	Compatible with Immunoassay andHPLC HbA1c test methods.	Beckman Coutler Sychron
Matrix	Human Blood	Human and Bovine Serum
Control Form	Liquid	Liquid
Levels	1-4 (4)	A-E (5)
Storage	-20°C	2°C to 8°C
Stability	Unopened vial stability (-20°C):2 YearsOpened vial stability (2-8°C):14 days	Unopened vial stability (2-8°C):3 YearsOpened vial stability (2-8°C):14 days

Summary:

The information provided in this pre-market notification demonstrates that Cone Bioproducts' A l c Linearity Set is substantially equivalent to LiniCAL Enzyme Calibration Verifiers (K040535). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate device. The information supplied in this pre-market notification provides reasonable assurance that the Cone Bioproducts' A1c Linearity Set is safe and effective for its stated intended use.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 4 - 2005

Mr. William Cone Regulatory Affairs Officer Cone Bioproducts 1008 N. River Street Seguin, TX 78155

Re: K052010

Trade/Device Name: Cone Bioproducts HbA1c Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 1, 2005 Received: September 16, 2005

Dear Mr. Cone:

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).

{3}------------------------------------------------

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.

Carol C. Benson

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

SECTION III

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indications for Use

510(k) Number (if known): ________k052010

Device Name: Cone Bioproducts' HbA Ic Linearity Set

Indications For Use:

Hemoglobin Alc Linearity is intended for use as quality control material to demonstrate linearity throughout the richtogloum ATC 2nioans 13 interest to 125 as quarty and HPLC test methods using protocols established in individual laboratories.

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 Dingnostic Device Evaluation and Sarely

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.