AUDIT MICROCV HS-CRP LINEARITY SET

K101427 · Aalto Scientific, Ltd. · JJX · Dec 23, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101427
• Device Name: AUDIT MICROCV HS-CRP LINEARITY SET
• 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™ MicroCV™ hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM hs-CRP Linearity Set is "For In Vitro Diagnostic Use Only".

Device Story

Audit™ MicroCV™ hs-CRP Linearity Set; human-based serum QC material; five-level liquid set; contains hs-CRP analyte. Used in clinical laboratories to verify calibration, linear operating range, and reportable range of quantitative hs-CRP assays. Levels A-E demonstrate linear relationship via dilution; Level A near lower limit, Level E near upper limit. Laboratory personnel use material to simulate patient samples; monitor systematic analytical deviations; establish internal means/ranges. Benefits include improved accuracy and reliability of hs-CRP testing; ensures instrument performance within specified linear range.

Clinical Evidence

Bench testing only. Stability studies performed to determine shelf life. Open vial stability: 10 days at 2-8°C. Shelf life: 2 years at 2-8°C. No clinical data.

Technological Characteristics

Human-based serum matrix; liquid form; contains hs-CRP analyte; preserved with sodium azide. Five-level set; 2 mL per vial. Storage at 2-8°C. No stabilizers. In vitro diagnostic use.

Indications for Use

Indicated for use as an assayed quality control material to monitor and detect systematic analytical deviations in laboratory testing procedures for High Sensitivity C-Reactive Protein (hs-CRP) in human serum samples.

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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#### 510(k) Summary

#### A. Submitter

DEC 2 3 2010

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

Desember 23, 2010

#### D. Device Identification

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

Audit™ MicroCVTM hs-CRP Linearity Set hs-CRP Linearity Assay QC Material Class I 21 CFR 862.1660 7 ર JJX

### 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 hs-CRP Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: High Sensitivity C-Reactive Protein (hs -CRP). It is used to confirm the proper calibration, linear operating range, and reportable range of hs-CRP. 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.

## G. Statement of Intended Use

The Audit™ MicroCVTM hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCV™ hs-CRP Linearity Set is "For In Vitro Diagnostic Use Only".

## I. Summary of Performance Data

Stability studies have been performed to determine the shelf life for the Audit™ MicroCV™ hs-CRP 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, High Sensitivity C-Reactive Protein (hs -CRP) will be stable for 10 days when stored tightly capped at 2-8 C.

Shelf Life: Two years at 2 - 8º C.

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

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Image /page/2/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo consists of a triangle shape made up of smaller triangles, with the company name written below it. The text "Aalto Scientific, Ltd." is in a simple, sans-serif font. The year 2018 is also present in the image.

| Characteristics | Audit™ MicroCVTM hS-CRP<br>Linearity Set<br>(K101427) | Audit™ MicroCVTM General Chemistry<br>Linearity Set<br>(K042318) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit™ MicroCVTM hs-CRP Linearity<br>Set is assayed quality control material<br>consisting of five levels human based serum.<br>Each level contains High Sensitivity C-<br>Reactive Protein (hs -CRP) analyte. The five<br>levels demonstrate a linear relationship to<br>each other for High Sensitivity C-Reactive<br>Protein (hs -CRP) analyte. It is intended to<br>simulate human patient serum samples for<br>purpose of monitoring and detecting<br>systematic analytical deviations of laboratory<br>testing procedures for High Sensitivity C-<br>Reactive Protein (hs -CRP). This product<br>may be used as quality control material for<br>High Sensitivity C-Reactive Protein (hs -<br>CRP) analyte. When used for quality control<br>purposes, it is recommended that each<br>laboratory establish its own means and<br>acceptable ranges and use the values<br>provided only as guides. The product is<br>intended for use with quantitative assays on<br>the indicated analyzer provided in the<br>labeling,The Audit™ MicroCV™ hs-CRP<br>Linearity Set is "For In Vitro Diagnostic Use<br>Only". | Audit™ MicroCVTM General Chemistry<br>Linearity Set is assayed quality control<br>material consisting of human based serum. It<br>is intended to simulate human patient serum<br>samples for the purpose of monitoring the<br>precision and to detect systematic analytical<br>deviations of laboratory testing procedures.<br>This product may also be used as unassayed<br>quality control material for these same<br>analytes. |
| Number of<br>Analytes per vial | 1 | 30 |
| Number of levels<br>per set | 5 | 5 |
| Contents | 5 x 2 mL | 5 x 5 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Clinical Chemistry | General Chemistry |
| 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 Vial Stability | 10 days at 2-8 °C | 7 days at 2 to 8° C except for enzymes and<br>bilirubin |

# H. Technical Characteristics Compared to Predicate Device

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Image /page/3/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangle shape made up of many smaller circles or dots. Below the triangle, the text "Aalto Scientific, Ltd." is written in a stylized font. The text "Andro" is also present, but it is unclear if it is part of the logo or separate text.

## 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element on the left and a stylized graphic on the right. The text element contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic on the right depicts a stylized eagle or bird-like figure with outstretched wings.

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: k101427

> Trade Name: Audit™ MicroCV™ HS-CRP 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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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.

C.C.

Courmey 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 (if known): K101427

DEC 2 3 2010

Device Name: Audit™ MicroCV™ hs -CRP Linearity Set

Indications For Use:

The Audit™ MicroCV™ hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM hs-CRP 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 C Benson
ion Sign-Off

Cice of In Vitro Diagnostic Device Branstion and Safety

K101427