DROPPER A1C DIABETES CONTROL

K103744 · Quantimetrix Corp. · JJX · May 12, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103744
• Device Name: DROPPER A1C DIABETES CONTROL
• Applicant: Quantimetrix Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.

Device Story

Dropper A1c Diabetes Control is a quality control material for HbA1c laboratory assays. It consists of two levels of frozen liquid whole blood matrix, fortified with reagent-grade chemicals to represent threshold and pathological HbA1c ranges. The device is used in clinical laboratory settings to verify the accuracy and precision of HbA1c testing procedures on specific analyzers (e.g., Beckman Coulter Synchron, Roche Cobas, Siemens DCA 2000/Vantage). Laboratory technicians use the control by running it through the same analytical process as patient samples. By comparing the measured HbA1c values against the established mean and range provided for each analyzer, clinicians ensure the reliability of patient test results, thereby supporting accurate diabetes management and monitoring.

Clinical Evidence

No clinical data. Performance is based on analytical value assignment and stability testing. Value assignment was conducted by running each control level once per day for three days across multiple operators on specified analyzers. Stability was validated via accelerated and real-time studies to support claims for closed and open vial storage durations.

Technological Characteristics

Frozen liquid whole blood matrix; fortified with reagent-grade chemicals; contains preservatives to inhibit microbial growth. Two levels provided: threshold and pathological. Compatible with specific clinical chemistry analyzers. Stability: Closed vial (180 days at 2-8°C), Open vial (180 days at 2-8°C or 21 days at 18-25°C).

Indications for Use

Indicated for use as a quality control material for laboratory procedures measuring HbA1c levels. No specific patient population, age, or gender restrictions apply as it is a laboratory control product.

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

• MAS Diabetes Control (k023307)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image features the logo of Quantimetrix Corporation on the lower left side. The logo consists of the letters 'QC' in a stylized font, with the full name of the corporation written below. In the upper right corner, there is a handwritten alphanumeric code 'K103744'. The background is a combination of white and black, with a curved line separating the two colors.

## 510K Summary

Dec. 14, 2010 Prepared:

Submitted by: Quantimetrix Corporation

Establishment Address:

Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach CA 90278 Phone: [phone] FAX: [phone]

Establishment Registration Number: 2020715 Contact Person: Kalyna Snylyk, Director of Ouality Assurance & Regulatory Affairs Proprietary Name: Dropper A1c Diabetes Control Common Name: Hemoglobin A1c Control Classification Name: Single (Specified) Analyte Quality Control Material (Assayed and Unassayed), (21 CFR 862.1660) Product Code: JJX

Substantial Equivalence:

The Quantimetrix Dropper Alc Diabetes Control is supplied as a frozen liquid in two levels and consists of a human whole blood matrix containing preservatives to which reagent grade chemicals were added to chemically react with the hemoglobin to achieve the two levels.

The Quantimetrix controls are substantially equivalent to other such controls in general use, such as the MAS Diabetes Control, sold by Microgenics Corporation Inc., which is supplied liquid in two levels as a whole blood matrix with pure chemicals added by the manufacturer.

Assayed values are determined from in-house data.

www.4ac.co 800,624.8380 | 310,536.0006 tel [phone].536.9977 fax 2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278 USA

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Image /page/1/Picture/0 description: The image shows the logo for Quantimetrix Corporation. The logo consists of the letters 'QC' stacked on top of each other, with the word 'Quantimetrix' written below the letters. The word 'Corporation' is written below 'Quantimetrix'. The logo is in black and white and is placed on a white background with a black curved line at the top.

Description:

Dropper A1c Controls are supplied in two levels, 4 bottles total, 2 x 2 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a whole blood matrix fortified to target levels with reagent grade chemicals added to achieve the two levels. Preservatives have been added to inhibit microbial growth.

Intended Use:

The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.

Technological Characteristics Compared to Predicate Devices:

The Quantimetrix control product employs a similar matrix and constituent formulation to the equivalent predicate device listed above: whole blood matrix fortified with reagent grade chemicals as well as preservatives. The Quantimetrix Control also has similar storage and stability requirements as the equivalent devices.

Image /page/1/Picture/7 description: This image contains contact information for a company. The website is www.4qc.com. The phone numbers are 800.624.8380 and 310.536.0006, and the fax numbers are 800.624.1834 and 310.536.9977. The address is 2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278 USA.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name encircling the image and a stylized symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY 1 2 2011

Quantimetrix Corporation c/o Kalyna Snylyk Director, Quality Assurance/Regulatory Affairs 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278

Re: k103744

> Trade Name: Dropper A1c Diabetes Control Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: December 17, 2010 Received: March 7, 2011

Dear Ms. Snylyk:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFR Parls 801 and 5450. Also, please note the regulation entitled, "Misoranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Enclosure

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## Indications for Use Form.

510(k) Number (if known):

Dropper™ A1c Diabetes Control Device Name:

## Indications for Use:

The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-CounterUse _ AND/OR (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

510(k) K103744

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