AUDIT MICROCV IMMUNOASSAY LINEARITY SET

K062668 · Aalto Scientific, Ltd. · JJY · Oct 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062668
• Device Name: AUDIT MICROCV IMMUNOASSAY LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Immunoassay Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived immunoassay testing methods as identified in the package insert.

Device Story

Audit™ MicroCV™ Immunoassay Linearity Set is a lyophilized, five-level quality control material containing 17 analytes in a human and bovine serum albumin matrix. Levels A-E are prepared via linear dilution to span the reportable range of clinical analyzers. Used in clinical laboratories for proficiency testing, CLIA-directed calibration verification, and as assayed/unassayed quality control material. The healthcare provider reconstitutes the material and runs it on specified analyzer systems; results are compared against target values to verify instrument linearity and performance. Benefits include ensuring accurate measurement of immunoassay analytes and compliance with CLIA-88 regulatory requirements.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed reconstituted stability of 5 days at 2-8°C and a shelf life of two years when stored unopened at 2-8°C.

Technological Characteristics

Lyophilized, five-level set; human and bovine serum albumin matrix; contains 17 analytes and preservatives. Levels A-E are equidistant concentrations. Storage at 2-8°C. Reconstituted stability: 5 days at 2-8°C. Intended for use as assayed QC material only for specific instruments listed in package insert.

Indications for Use

Indicated for use as a quality control material to verify and validate the Analytical Measurement Range for non-waived immunoassay testing methods, including Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. Used for proficiency testing and CLIA-directed calibration verification. Can serve as unassayed QC or assayed QC for specified analyzer systems.

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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Image /page/0/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo consists of a triangle made up of many smaller triangles. Below the triangle is the text "Aalto Scientific, Ltd." in a serif font.

KCX62668

#### 510(k) Summary

## A. Submitter

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

OCT 16 2006

#### B. Contact Person

Alan Vekich Regulatory Affairs Specialist Telephone: [phone] ext. 120 E-mail: [e-mail]

# C. Date of Summary Preparation

September 2006

### D. Device Identification

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

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

# E. Device to Which Substantial Equivalence is Claimed

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

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Image /page/1/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo features a triangular shape made up of many small dots, resembling a stylized mountain or pyramid. Below the triangular shape, the text "Aalto Scientific, Ltd." is printed in a simple, sans-serif font.

# F. Description of the Device

The Audit™ MicroCV™ Immunoassay Linearity Set is a Human and Bovine serum albumin based, lyophilized, five level set of QC material, with each level containing 17 analyters It is used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for the analytes listed using FDA accepted reagents for the appropriate instrumentation in accordance with current CLIA-88 guidelines and regulations. In apdrtions Level A ~ E of this product may be used as an unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. Where Level A is near the lower limit of instruments 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. It is not intended to be used as an assayed quality control material for any other analyzer systems.

#### G. Statement of Intended Use

The Immunoassay Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived immunoassay testing methods as identified in the package insert.

| Characteristics | Audit™ MicroCV™ Immunoassay<br>Linearity Set<br>(New Device) | Audit™ MicroCV™ General Chemistry<br>Linearity Set<br>(K042318) |
|--------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | Linear, calibration verification quality<br>control material | Linear, calibration verification quality<br>control material |
| Number of<br>Analytes per vial | 17 | 30 |
| Number of levels<br>per set | 5 | 5 |
| Contents | 5 x 5 mls | 5 x 5 mls |
| Matrix | Human and Bovine Serum Albumin | Human Based Serum |
| Type of Analytes | Immunoassay | General Chemistry |
| Form | Lyophilized | Lyophilized |
| Preservative | Yes | Yes |
| Storage | 2 to 8° C<br>Until expiration date | 2 to 8° C<br>Until expiration date |
| Reconstituted<br>Stability | 5 days at 2 to 8° C | 7 days at 2 to 8° C except for enzymes<br>and bilirubin, which are 48 hours |

#### H. Technical Characteristics Compared to Predicate Device

K062668 Pg 2 of 3

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Image /page/2/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape composed of many small circles or dots, creating a textured effect. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.

## I. Summary of Performance Data

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

- Reconstituted Stability: Once a vial has been reconstituted, all analytes will be stable for 5 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.

#### 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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Alan Vekich Regulatory Affairs Specialist Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad. CA 92008

#### OCT 1 6 2006

Re: k062668 Trade/Device Name: Audit™ MicroCV™ Immunoassay Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 8, 2006 Received: September 13, 2006

Dear Mr. Vekich:

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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This letter will allow you to begin marketing your device as described in your Section \$10(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,

Alberto Gutz

Alberto Gutierrez, 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): K 062 1268

Audit™ MicroCV™ Immunoassay Linearity Set Device Name:

Indications For Use:

The Audit™ MicroCV™ Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.

This product may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.

In addition, Level A – E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.

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)