HBA1C LINEARITY SET

K052010 · Cone Bioproducts · JJX · Oct 4, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052010
• Device Name: HBA1C LINEARITY SET
• Applicant: Cone Bioproducts
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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 using protocols established by individual laboratories. For Prescription Use Only. For In vitro diagnostic use.

Device Story

HbA1c Linearity Set is a liquid quality control material derived from human blood with added stabilizers; used in clinical laboratories to verify linearity of HbA1c assays. Product consists of four levels; Level 1 and Level 4 represent the lower and upper limits of the manufacturer's claimed linearity; Levels 2 and 3 are admixtures. Laboratory personnel run all levels in triplicate on their specific immunoassay or HPLC analyzer. Results are compared against target concentrations to assess instrument performance across the reportable range. Benefits include ensuring accuracy and reliability of HbA1c measurements used for diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (accelerated and real-time) confirmed 2-year closed-vial stability at -20°C and 14-day open-vial stability at 2-8°C. Traceability established to the National Glycohemoglobin Standardization Program (NGSP) and Diabetes Control and Complications Trial (DCCT) reference method.

Technological Characteristics

Liquid control material prepared from human blood with stabilizers. Four-level set. Traceable to NGSP/DCCT reference method. Storage: -20°C (closed), 2-8°C (open).

Indications for Use

Indicated for use as quality control material to demonstrate linearity of HbA1c% for Immunoassay and HPLC test methods in clinical laboratories.

Regulatory Classification

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.

Predicate Devices

• LiniCAL Enzyme Calibration Verifiers (k040535)

Submission Summary (Full Text)

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# 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: [phone] Facsimile: [phone]

## Contact Person:

William K. Cone Regulatory Affairs Officer Telephone: [phone] ext. 203 Facsimile: [phone]

## 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:

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.

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# Comparison to Predicate Device(s):

Cone Bioproducts' HbA1c Linearity Set is substantially equivalent to LiniCAL Enzyme Calibration Verifiers (k040535) for its stated intended use.

| Device<br>Characteristics | Subject Device<br>Hemoglobin A1c Linearity Set | Predicate Device(s)<br>LiniCAL Enzyme Calibration<br>Verifiers (k040535) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Hemoglobin A1c Linearity is intended<br>for use as quality control material to<br>demonstrate the linearity of<br>Hemoglobin A1c (HbA1c%) for<br>Immunoassay and HPLC test methods<br>using protocols established in<br>individual laboratories. | LiniCAL Enzyme Calibration<br>Verifiers are intended for use in the<br>clinical laboratory to verify<br>calibration and/or linearity of the<br>Beckman Coulter Synchron Protein<br>Systems. Five assayed levels of<br>Alkaline Phosphatase, Alanine<br>Aminotransferase, Amylase, Asparate<br>Aminotransferase, Cholinesterase,<br>Creatine Kinase, Creatine Kinase MB,<br>Lactate Dehydrogenase, Lipase,<br>Gamma Glutamyl Transferase, and<br>Pancreatic Amylase are provided to<br>allow monitoring of the reportable<br>range. |
| Analyte | Single Constituent :<br>A1c | Multiple Constituents:<br>Alkaline Phosphatase, Alanine<br>Aminotransferase, Amylase, Asparate<br>Aminotransferase, Cholinesterase,<br>Creatine Kinase, Creatine Kinase MB,<br>Lactate Dehydrogenase, Lipase,<br>Gamma Glutamyl Transferase, and<br>Pancreatic Amylase |
| Methodology/<br>Analyzers | Compatible with Immunoassay and<br>HPLC 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):<br>2 Years<br><br>Opened vial stability (2-8°C):<br>14 days | Unopened vial stability (2-8°C):<br>3 Years<br><br>Opened vial stability (2-8°C):<br>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.

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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).

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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 [phone]. 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 [phone] or [phone] 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

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# SECTION III

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# 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)

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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