AUDIT MICROCV PROTEIN LINEARITY SET

K101216 · Aalto Scientific, Ltd. · JJY · Jan 14, 2011 · Clinical Chemistry

Device Facts

• Record ID: K101216
• Device Name: AUDIT MICROCV PROTEIN LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Audit™ MicroCV™ Protein Linearity is assayed quality control material consisting of five levels protein (human) based serum. Each level contains Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin analytes. The five levels demonstrate a linear relationship to each other for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Protein Linearity Set is "For In Vitro Diagnostic Use Only."

Device Story

Audit™ MicroCV™ Protein Linearity Set is a human serum-based quality control material; provided in five levels with linear concentration relationships for seven specific protein analytes (Alpha-1-Antitrypsin, Complement C3, Complement C4, IgG, IgA, IgM, Transferrin). Used in clinical laboratories to verify calibration, linear operating range, and reportable range of quantitative diagnostic analyzers. Clinicians/technicians process the control material alongside patient samples; results are compared against expected values to identify systematic analytical deviations or instrument drift. Benefits include ensuring accuracy and reliability of patient test results. Device is liquid-stable when stored at 2-8°C.

Clinical Evidence

Bench testing only. Stability studies performed to determine open vial stability (1 day at 2-8°C) and shelf life (1 year at 2-8°C). No clinical data provided.

Technological Characteristics

Human serum-based matrix; liquid form; contains sodium azide preservative. Five-level set with linear dilution relationship. Storage at 2-8°C. Analyte panel: Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin.

Indications for Use

Indicated for use as an assayed quality control material to monitor the performance of quantitative laboratory assays for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. Intended for professional in vitro diagnostic use in clinical laboratory settings to simulate human serum and detect systematic analytical deviations.

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

• Audit™ MicroCV™ General Chemistry Linearity Set (K042318)

Submission Summary (Full Text)

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# K101Z16

### 510(k) Summary

## A. Submitter

JAN 1 4 2011

く

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

## B. Contact Person

E-mail: Dessi Lyakov Telephone: [phone] Ext. 118 E-mail: dlyakov(@aaltoscientific.com

## C. Date of Summary Preparation

December 03, 2010

D. Device Identification

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

Audit™ MicroCVTM Protein Linearity Set Protein Linearity Assay QC Material Class I 21 CFR 862.1660 75 JJY

# E. Device to Which Substantial Equivalence is Claimed

Audit™ MicroCVTM General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318

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# F. Description of the Device

The Audit™ MicroCVTM Protein Linearity Set is a human based, five level set of QC material, with each level containing seven analytes: Aipha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. It is used to confirm the proper calibration, linear operating range, and reportable range of the analytes listed. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

## G. Statement of Intended Use

The Audit™ MicroCV™ Protein Linearity is assayed quality control material consisting of five levels protein (human) based serum. Each level contains Alpha-1-Antitrypsin, Complement C3. Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin analytes. The five levels demonstrate a linear relationship to each other for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Alpha-1-Antitrypsin. Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Protein 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 Protein 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, all analytes will be stable for 1 day when stored tightly capped at 2 - 8° C.

Shelf Life: One year, 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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| Characteristics | Audit™ MicroCV™ Protein Linearity<br>Set<br>(K101216) | Audit™ MicroCV™ General Chemistry<br>Linearity Set<br>(K042318) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit™ MicroCV™ Protein<br>Linearity is assayed quality control<br>material consisting of five levels<br>protein (human) based serum. Each<br>level contains Alpha-1-Antitrypsin,<br>Complement C3, Complement C4,<br>Immunoglobulin G, Immunoglobulin<br>A, Immunoglobulin M and<br>Transferrin analytes. The five levels<br>demonstrate a linear relationship to<br>each other for Alpha-1-Antitrypsin,<br>Complement C3, Complement C4,<br>Immunoglobulin G, Immunoglobulin<br>A, Immunoglobulin M, and<br>Transferrin analytes. It is intended to<br>simulate human patient serum<br>samples and to detect systematic<br>analytical deviations of laboratory<br>testing procedures for Alpha-1-<br>Antitrypsin, Complement C3,<br>Complement C4, Immunoglobulin G,<br>Immunoglobulin A, Immunoglobulin<br>M, and Transferrin. The product is<br>intended for use with quantitative<br>assays on the indicated analyzer<br>provided in the labeling. The Audit<br>MicroCV Protein Linearity Set is<br>"For In Vitro Diagnostic Use Only." | Audit™ MicroCV™ General Chemistry<br>Linearity Set is assayed quality control<br>material consisting of human based<br>serum. It is intended to simulate human<br>patient serum samples for the purpose<br>of monitoring the precision and to<br>detect systematic analytical deviations<br>of laboratory testing procedures. This<br>product may also be used as unassayed<br>quality control material for these same<br>analytes. |
| Number of<br>Analytes per vial | 7 | 30 |
| Number of<br>levels per set | 5 | 5 |
| Contents | 5 x 2 mL | 5 x 5 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type of<br>Analytes | Clinical Chemistry | General Chemistry |

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# H. Technical Characteristics Compared to Predicate Device

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| Form | Liquid | Lyophilized |
|--------------------------|------------------------------------|------------------------------------|
| Stabilizers | None | None |
| Preservatives | Sodium Azide | Sorbitol<br>Sodium azide |
| Storage | 2 to 8° C<br>Until expiration date | 2 to 8° C<br>Until expiration date |
| Open Bottle<br>Stability | 24 hours at 2 to 8° C | 24 hours at 2 to 8° C |

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# J. Conclusions '

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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Silver Spring, MD 20993

Food and Drug Administration

10903 New Hampshire Avenue

Image /page/5/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing the federal government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Aalto Scientific c/o Dessi Lyakov 1959 Kellogg Ave. Carlsbad. CA 92008

Re: k101216

Trade Name: Audit Micro CV Protein Linearity Set Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control. Regulatory Class: Class I, reserved Product Codes: JJY Dated: December 3, 2010 Received: December 7, 2010

JAN 1 4 20:1

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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#### Page 2 -

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.

GJC.

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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# Indications for Use

510(k) Number: ¥10126

Device Name: Audit™ MicroCV Protein Linearity Set

Indications For Use:

The Audit™ MicroCV™ Protein Linearity is assayed quality control material consisting of five levels protein (human) based serum. Each level contains Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin analytes. The five levels demonstrate a linear relationship to each other for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin A, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Protein Linearity Set is "For In Vitro Diagnostic Use Only."

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Signature

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K101216

Aalto Scientific, Ltd. 510(k) Notification Audit™ MicroCVTM Protein Linearity Set