AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5

K100715 · Aalto Scientific, Ltd. · JJX · Dec 23, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100715
• Device Name: AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".

Device Story

Audit™ MicroCV™ Homocysteine Linearity Set is a human serum-based, liquid, five-level quality control material; contains Homocysteine analyte. Levels A-E provide a linear relationship for verifying instrument performance; Level A near lower limit; Level E near upper limit; Levels B-D prepared via linear dilution. Used in clinical laboratories to confirm calibration, linear operating range, and reportable range of quantitative Homocysteine assays. Not for calibration or standardization. Benefits include ensuring analytical accuracy and reliability of patient test results; aids in detecting systematic analytical deviations. Operated by laboratory technicians; results interpreted by healthcare providers to validate assay performance before reporting patient data.

Clinical Evidence

Bench testing only. Stability studies conducted to determine open vial stability (10 days at 2-8°C) and shelf life (2 years at 2-8°C). No clinical data provided.

Technological Characteristics

Human serum-based liquid matrix; 5 levels per set; 1 analyte (Homocysteine). Storage 2-8°C. Open vial stability 10 days at 2-8°C. Shelf life 24 months. In vitro diagnostic use.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient serum samples for determining linearity, calibration verification, and verification of reportable range for Homocysteine quantitative assays in a clinical laboratory setting.

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

• Liquichek Homocysteine Control (K984071)
• Audit MicroCV General Chemistry Linearity Set (K042318)

Submission Summary (Full Text)

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K100715

DEC 2 3 2010

#### 510(k) Summary

#### A. Submitter

Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: [phone] Fax: [phone]

#### B. Contact Person

Dessi Lyakov Telephone: [phone] Ext. 118 E-mail: [e-mail]

### C. Date of Summary Preparation

December 23, 2010

### D. Device Identification

Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:

Audit™ MicroCVTM Homocysteine Linearity Set Homocysteine Linearity Set Assay QC Material Class I 21 CFR 862.1660 75 JJX

## E. Device to Which Substantial Equivalence is Claimed

Product Trade Name:

Liquichek Homocysteine Control Bio-Rad Laboratories, Irvine, California K984071

Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318

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## Description of the Device

The Audit™ MicroCV™ Homocysteine Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Homocysteine. It is used to confirm the proper calibration, linear operating range, and reportable range of Homocysteine. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B - D are related by linear dilution of Level A and Level E.

## Statement of Intended Use

The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".

## I. Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCVTM Homocysteine Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:

Open Vial Stability: Once a vial has been opened. Homocysteine will be stable for 10 days when stored tightly capped at 2 - 8° C.

Shelf Life: Two years, when stored unopened at 2 - 8° C,

Note: Real time studies are ongoing to support the shelf life of this product.

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# H. Technical Characteristics Compared to Predicate Device

| | Audit™ MicroCV™ | Bio-Rad Liquichek | Audit™ MicroCV™ General |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Homocysteine Linearity Set | Homocysteine Control (K984071) | Chemistry Linearity Set<br>(K042318) |
| Intended Use | The Audit™ MicroCV™<br>Homocysteine Linearity Set is<br>assayed quality control<br>material consisting of five<br>levels human based serum.<br>Each level contains<br>Homocysteine analyte. The<br>five levels demonstrate a<br>linear relationship to each<br>other for Homocysteine<br>analyte. It is intended to<br>simulate human patient serum<br>samples for purpose of<br>determining linearity,<br>calibration verification and<br>verification of reportable<br>range for Homocysteine. The<br>product is intended for use<br>with quantitative assays on the<br>indicated analyzer provided in<br>the labeling. The Audit™<br>MicroCV™ Homocysteine<br>Linearity Set should not be<br>used for calibration or<br>standardization of the<br>Homocysteine assay. The<br>Audit™ MicroCV™<br>Homocysteine Linearity Set is<br>"For In Vitro Diagnostic Use<br>Only". | A liquid control for<br>monitoring<br>homocysteine test<br>procedures. This<br>product can be used<br>for methods such as<br>HPLC and automated<br>immunoassay. | Audit™ MicroCV™ General<br>Chemistry Linearity Set is assayed<br>quality control material consisting of<br>human based serum. It is intended to<br>simulate human patient serum samples<br>for the purpose of monitoring the<br>precision and to detect systematic<br>analytical deviations of laboratory<br>testing procedures. This product may<br>also be used as unassayed quality<br>control material for these same<br>analytes. |
| Number of<br>Analytes per vial | 1 | 1 | 31 |
| Number of levels<br>per set | 5 | 2 | 5 |
| Contents<br>Matrix | 5 x 1mL<br>Human Serum | 6 x 1mL<br>Human Serum | 5 x 5 mL<br>Human Serum |
| Type of Analytes | Homocysteine | Homocysteine | Total Protein, Albumin, Alkaline<br>Phosphatase, ALT, Amylase, AST,<br>Bilirubin (Total and Direct), BUN,<br>Calcium, Chloride, Cholesterol, CO2,<br>Creatine Kinase, Creatinine, Gamma-<br>GT, Glucose, HDL Cholesterol, Iron,<br>LDH, LDL Cholesterol, Lactate,<br>Lipase, Magnesium, Phosphorus,<br>Potassium, Sodium, Total Protein, |
| Form | Liquid | Liquid | Lyophilized |
| Storage | 2 to 8° C<br>for 24 months | -10 to -70° C<br>for 36 months | 2 to 8° C for 24 months |
| Open Bottle<br>Stability | 10 days at 2 to 8° C | 14 days at 2 to 8° C | 7 days at 2 to 8° C |

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Based upon the purpose of the device, the descriptions and labeling of the predicate device, the safety and efficacy, and the stability data generated, the product is substantially equivalent to the predicate device.

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

AALTO Scientific LTD. c/o Ms. Dessi Lyakov Manager, Regulatory Affairs 1959 Kellogg Avenue Carlsbad, CA 92008

DEC 2 3 2010

Re: k100715

> Trade Name: Audit™ MicroCV™ Homocysteine Linearity Set Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: November 22, 2010 Received: November 23, 2010

Dear Ms. Lyakov:

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 and Safety at [phone]. Also, please note the regulation entitled, "Misbranding 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 free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

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

Enclosure

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DEC 2 3 2010

510(k) Number: K100715

Device Name: Audit™ MicroCV™ Homocysteine Linearity Set

Indications For Use:

The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".

Prescription Use X (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)

Carol Benson
Sign-Off

്ചാ of In Vitro Diagnostic Device -tion and Safety

K100715