AUDIT MICROCV IMMUNOASSAY LINEARITY SET

K103601 · Aalto Scientific, Ltd. · JJY · Jun 10, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103601
• Device Name: AUDIT MICROCV IMMUNOASSAY LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. This product may also be used as a quality control material for these analytes. 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 automatic analyzers. The Audit™ Free T4 / Free T3 Linearity Set is “For In Vitro Diagnostic Use Only”.

Device Story

Audit™ MicroCV™ Free T4 / Free T3 Linearity Set is a 5-level quality control solution; human and bovine albumin-based matrix; contains Free T4 and Free T3 analytes. Used in clinical laboratories to verify calibration, linear operating range, and reportable range of quantitative assays on automatic analyzers; also serves as quality control material. Levels A-E represent concentrations across the analytical range; Levels B-D are linear dilutions of A and E. Healthcare providers use the output to monitor instrument performance and ensure accuracy of patient test results. Benefits include improved diagnostic reliability through validated instrument linearity.

Clinical Evidence

No clinical data. Bench testing only. Linearity verified using CLSI EP6-A guidelines; regression analysis performed on Biomerieux Mini-Vidas and Siemens Centaur analyzers. Stability (shelf life 24 months, open vial 5 days) confirmed with recovery within ±15%.

Technological Characteristics

Matrix: Human and bovine serum albumin. Form: Lyophilized. Levels: 5. Storage: 2–8 °C. Analyte assignment: Repeat analysis on automated immunoassay analyzers. Linearity verification: CLSI EP6-A statistical approach. Connectivity: None (standalone control material).

Indications for Use

Indicated for use as a quality control material and linearity verification tool for Free T4 and Free T3 quantitative assays on automatic analyzers in clinical laboratory settings.

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™ Immunoassay Linearity Set (k062668)

Submission Summary (Full Text)

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# 1103601

JUN 1 0 2011

510(k) Summary

A. Submitter

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

B. Contact Person

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

C. Date of Summary Preparation

June 7, 2011

D. Device Identification

| Product Trade Name: | Audit™ MicroCV™ Free T4 / Free T3 Linearity Set |
|------------------------|-------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Multi analyte controls (Assayed and Unassayed) |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJY |

E. Legally marketed (unmodified) device

Product Trade Name:

Audit MicroCV Free T4 / Free T3 Linearity Set Aalto Scientific, Ltd., Carlsbad, California K062668

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## F. Description of the Modified Device

The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set is a 5 level quality control solution set containing Free T4 / Free T3 analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of Free T4 / Free T3 analytes. 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.

### Statement of Intended Use

The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.

This product may also be used as a quality control material for these analytes. 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 automatic analyzers. The Audit™ Free T4 / Free T3 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™ MicroCV™ Free T4 / Free T3 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 reconstituted, all analytes will be stable for 5 days when stored tightly capped at 2-8 C.

Shelf Life: 24 months 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 Unmodified Device

.

| Characteristics | Audit™ MicroCV™<br>Free T4 / Free T3 Linearity Set<br>K103601 | Audit™ MicroCV™<br>Immunoassay Linearity Set<br>K062668 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit™ MicroCV™ Free T4 / Free<br>T3 Linearity Set consists of five levels<br>of human and bovine albumin based<br>matrix. Each level contains the<br>following analytes: Free T4 and Free<br>T3. The five levels demonstrate a<br>linear relationship to each other for<br>their respective analytes, reagents,<br>and instruments.<br>This product may also be used as a<br>quality control material for these<br>analytes. When used for quality control<br>purposes, it is recommended that each<br>laboratory establish its own means<br>and acceptable ranges and use the<br>values provided only as guides. The<br>product is intended for use with<br>quantitative assays on automatic<br>analyzers. The Audit™ Free T4 / Free<br>T3 Linearity Set is "For In Vitro<br>Diagnostic Use Only". | Audit™ MicroCV™ Immunoassay<br>Linearity Set is assayed quality control<br>material consisting of human Albumin<br>based serum. It is intended to simulate<br>human patient serum samples for the<br>purpose of monitoring the precision<br>and to detect systematic analytical<br>deviations of laboratory testing<br>procedures. This product may also be<br>used as unassayed quality control<br>material for these same analytes and<br>may be used for proficiency testing in<br>interlaboratory surveys. In addition,<br>this product may also be used to<br>perform CLIA directed calibration<br>verification for these same analytes<br>with similar reagents on similar<br>instrumentation in accordance with<br>current CLIA-88 guidelines and<br>regulations. |
| Number of levels per set | 5 | 5 |
| Contents | 5 x 5mL | 5 x 5mL |
| Matrix | Human and Bovine Albumin Serum | Human and Bovine Albumin Serum |
| Type of Analytes | Free T4 and Free T3 | Cortisol, Digoxin, Estradiol, Ferritin,<br>Folate, Free T4, FSH, hCG, LH,<br>Progesterone, Prolactin, Testosterone,<br>Total PSA, Total T3, Total T4, TSH,<br>and Vitamin B12. |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8º C for 24 months | 2 to 8º C for 24 months |
| Open Bottle Stability | 5 days at 2 to 8° C | 5 days at 2 to 8° C |

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## J. Conclusions

Based upon the purpose of the device, the descriptions and labeling of the unmodified device, the safety and efficacy, the risk analyses, and the stability data generated, the modified product is practically identical to the unmodified device.

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Public Health Service

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

Aalto Scientific Ltd. c/o Dessi Lyakov, Regulatory Affairs Manager 1959 Kellogg Ave. Carlsbad. CA 92008

JUN 1 0 2011

Re: k103601

Trade/Device Name: Audit™ MicroCV™ FreeT4/FreeT3 Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I. reserved Product Code: JJY Dated: 24 March, 2011 Received: 29 March, 2011

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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(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.

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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,

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

510(k) Number: K103601

Device Name: Audit™ MicroCV Free T4 / Free T3 Linearity Set

Indications For Use:

The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.

This product may also be used as a quality control material for these analytes. 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 automatic analyzers. The Audit™ Free T4 / Free T3 Linearity Set is "For In Vitro Diagnostic Use Only".

Prescription Use × (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. Benam

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

510(k) K103601

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