AUDIT MICROCV CARDIAC MARKERS LINEARITY SET

K102617 · Aalto Scientific, Ltd. · JJY · Jan 10, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102617
• Device Name: AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Audit™ MicroCV™ Cardiac Markers Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains CKMB. Myoglobin, and Troponin I (Tnl) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When Audit™ MicroCVTM Cardiac Markers Linearity Set is 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 analyzers indicated in the labeling. The Audit™ Cardiac Markers Linearity Set is "For In Vitro Diagnostic Use Only".

Device Story

Audit™ MicroCV™ Cardiac Markers Linearity Set is a 5-level human serum-based quality control material; contains CKMB, Myoglobin, and Troponin I (TnI) analytes. Levels A-E provide a linear relationship for verifying instrument calibration, linear operating range, and reportable range. Used in clinical laboratories; operated by laboratory personnel. Output consists of assayed values used as guides for establishing laboratory-specific means and acceptable ranges. Benefits include ensuring accuracy and reliability of cardiac marker quantitative assays; supports compliance with quality control requirements.

Clinical Evidence

Bench testing only. Stability studies performed to determine open vial stability (5 days at 2-8°C) and shelf life (18 months at 2-8°C).

Technological Characteristics

Lyophilized human serum-based matrix; 5-level set; 1mL volume per vial. Analytes: CKMB, Myoglobin, Troponin I. Storage: 2-8°C. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control material for quantitative assays of CKMB, Myoglobin, and Troponin I (TnI) on clinical analyzers to confirm calibration, linear operating range, and reportable range.

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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K102617

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

#### 510(k) Summary

JAN 1 0 2011

### 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™ MicroCV™ Cardiac Markers Linearity Set Calibration Verification Multi analyte controls (Assayed and Unassayed) Class I 21 CFR 862.1660 75 JJY

### E. Device to Which Substantial Equivalence is claimed

Product Trade Name:

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

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Image /page/1/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape at the top, which appears to be composed of many small dots or pixels. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.

# F. Description of the Device

The Audit™ MicroCV™ Cardiac Markers Linearity Set is a 5 level quality control solution set containing CKMB, Myoglobin, and Tnl analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of CKMB, Myoglobin, and TnI 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™ Cardiac Markers Linearity Set is an assaved quality control material consisting of five levels human based serum. Each level contains CKMB. Myoglobin, and Troponin I (Tnl) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When Audit™ MicroCVTM Cardiac Markers Linearity Set is 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 analyzers indicated in the labeling. The Audit™ Cardiac Markers 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™ Cardiac Markers 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: 18 months at 2 - 8º 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

ﻟ ﻣﺎ

| | Audit™ MicroCV™<br>Cardiac Markers Linearity Set<br>(New) | Audit™ MicroCV™<br>General Chemistry Linearity Set<br>(K042318) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | |
| Intended Use | The Audit™ MicroCV™ Cardiac<br>Markers Linearity Set is an assayed<br>quality control material consisting of<br>five levels human based serum. Each<br>level contains CKMB, Myoglobin, and<br>Troponin I (TnI) analytes. The five<br>levels demonstrate a linear relationship<br>to each other for CKMB, Myoglobin,<br>and Tnl analytes. When Audit™<br>MicroCV™ Cardiac Markers Linearity<br>Set is used for quality control purposes,<br>it is recommended that each laboratory<br>establish its own means and acceptable<br>ranges and use the values provided only<br>as guides. The product is intended for<br>use with quantitative assays on the<br>analyzers indicated in the labeling. The<br>Audit™ Cardiac Markers Linearity Set<br>is "For In Vitro Diagnostic Use Only". | Audit® MicroCV™ General Chemistry Linearity Set<br>consists of five levels of human based serum. Each<br>level contains the following analytes: Albumin,<br>Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin<br>(Total and Direct), BUN, Calcium, Chloride,<br>Cholesterol, CO2, Creatine Kinase, Creatinine,<br>Gamma-GT, Glucose, HDL Cholesterol, Iron, Lactate,<br>LDH, LDL Cholesterol, Lipase, Magnesium,<br>Phosphorus, Potassium, Sodium, Total Protein,<br>Triglycerides and Uric Acid. These five levels<br>demonstrate a linear relationship to each other for their<br>respective analytes, reagents and instruments¹.<br>This product may also be used as unassayed quality<br>control material for these analytes. When used for<br>quality control purposes, it is recommended that each<br>laboratory establish its own means and acceptable<br>ranges and use the values provided only as guides. In<br>addition, it may be used for proficiency testing in<br>interlaboratory surveys and to perform CLIA directed<br>calibration verification² for these same analytes in<br>accordance with current CLIA-88 guidelines and<br>regulations³. |
| Number of levels per set | 5 | 5 |
| Contents | 5 x 1mL | 5 x 5mL |
| Matrix | Human Serum | Human Serum |
| Type of Analytes | CKMB,<br>Myoglobin,<br>and Troponin I (TnI) | Albumin, Alkaline Phosphatase, ALT, Amylase, AST,<br>Bilirubin (Total and Direct), BUN, Calcium, Chloride,<br>Cholesterol, CO₂, Creatine Kinase, Creatinine, Gamma-GT,<br>Glucose, HDL Cholesterol, Iron, Lactate, LDH, LDL<br>Cholesterol, Lipase, Magnesium, Phosphorus, Potassium,<br>Sodium, Total Protein, Triglycerides and Uric Acid. |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8° C for 18 months | 2 to 8° C for 48 months |
| Open Bottle Stability | 5 days at 2 to 8° C | 7 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 predicate device, the safety and efficacy, and the stability data generated, the product is substantially equivalent to the predicate device.

. ಹ

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of two main elements: a circular text element and a stylized graphic. The text element is arranged in a circle and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the text is a graphic of what appears to be a stylized human figure with outstretched arms, or possibly a bird in flight.

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

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

Re: k102617

> Trade Name: Audit™ MicroCV™ Cardiac Markers Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, Reserved Product Codes: JJY Dated: November 22, 2010 Received: November 23, 2010

> > JAN 1 0 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, Ythe 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 Diagnosuic 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-fre 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

:

Enclosure

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JAN 1 0 2011

K102617

# Indications for Use

510(k) Number: New

Device Name: Audit™ MicroCV Cardiac Markers Linearity Set

Indications For Use:

The Audit™ MicroCV™ Cardiac Markers Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains CKMB. Myoglobin, and Troponin I (Tnl) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When Audit™ MicroCVTM Cardiac Markers Linearity Set is 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 analyzers indicated in the labeling. The Audit™ Cardiac Markers 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

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

510(k) K 102617