AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5

K100718 · Aalto Scientific, Ltd. · JJY · Sep 3, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100718
• Device Name: AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is “For In Vitro Diagnostic Use Only.”

Device Story

Audit MicroCV Ammonia/Ethanol Linearity Set; protein (bovine)-based aqueous serum substitute; five levels (A-E) with linear concentration relationships. Used in clinical laboratories to verify calibration, linear operating range, and reportable range of ammonia and ethanol assays on Hitachi 911 analyzers. Levels A-E prepared via linear dilution; target values assigned via repeat analysis on Hitachi 911 using standardized ammonia and ethanol reagents. Healthcare providers use output to confirm analyzer performance and detect systematic analytical deviations; ensures accuracy of patient serum sample testing.

Clinical Evidence

No clinical data. Bench testing only. Linearity established per NCCLS EP6-A. Stability (closed vial 2 years, open vial 2 days) validated via accelerated and real-time studies. Traceability established to Pointe Scientific and Diagnostics Chemical Limited standards.

Technological Characteristics

Protein-based (bovine) serum matrix; liquid form; 5 levels per set; 2 analytes (Ammonia, Ethanol). Storage: 2-8°C. Open-vial stability: 2 days at 2-8°C. Shelf life: 2 years at 2-8°C.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient serum samples for the detection of systematic analytical deviations in laboratory testing procedures for Ammonia and Ethanol. Intended for use with quantitative assays on specified analyzers.

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

• Document® Ammonia/Ethanol Calibration Verification Rest Set (k944338)

Submission Summary (Full Text)

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510(k) Summary

K100718 SEP . 3 2010

#### A. Submitter

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

#### B. Contact Person

Dessi Lyakov Regulatory Affairs Manager [e-mail] [phone], Ext. 118

#### C. Date of Summary Preparation

February 26, 2010

### D. Device Identification

| Product Trade Name: | Audit™ MicroCV™ Ammonia/Ethanol Linearity<br>Set |
|------------------------|--------------------------------------------------|
| Common Name: | Ammonia/Ethanol Linearity |
| Classification Name: | Multi-analyte controls (Assayed and Unassayed) |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJY |

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

Product Trade Name:

Document Ammonia/Ethanol CAL•VER® Microgenics Corporation, Fremont, Ca K944338

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### F. Description of the Device

The Audit™ MicroCV™ Ammonia/Ethanol Linearity Set is a protein (bovine) based calibration verification material containing multiple levels used to confirm proper calibration, linear operating range, and reportable range of the measured analyte. 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 MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is "For In Vitro Diagnostic Use Only".

#### I. Summary of Performance Data

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

Once a vial has been opened, all analytes will be stable Open Vial Stability: for 2 days when stored stoppered at 2 - 8° C.

Shelf Life: 2 years, 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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Image /page/2/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo consists of a triangle made up of many small dots, with the company name written below it. The text is in a simple, sans-serif font and is left-aligned. The logo is black and white and appears to be of moderate resolution.

# H. Technical Characteristics Compared to Predicate Device

| Characteristics | Audit™ MicroCV™ Ammonia/Ethanol<br>Linearity Set<br>(K100718) | Microgenics Document<br>Ammonia/Ethanol CAL VER<br>(K944338) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit MicroCV<br>Ammonia/Ethanol Linearity Set is<br>assayed quality control material<br>consisting of five levels protein<br>(bovine) based serum. Each level<br>contains Ammonia and Ethanol<br>analytes. The five levels demonstrate<br>a linear relationship to each other for<br>Ammonia and Ethanol analytes. It is<br>intended to simulate human patient<br>serum samples and to detect<br>systematic analytical deviations of<br>laboratory testing procedures for<br>Ammonia and Ethanol. This product<br>may be used as unassayed quality<br>control material for Ammonia and<br>Ethanol analytes. The product is<br>intended for use with quantitative<br>assays on the indicated analyzer<br>provided in the labeling. The Audit<br>MicroCV Ammonia/Ethanol<br>Linearity Set is "For In Vitro<br>Diagnostic Use Only." | DOCUMENT Ammonia/Ethanol<br>CAL•VER® solutions are intended<br>for <i>in vitro</i> diagnostic use in the<br>quantitative determination of<br>linearity, calibration verification,<br>verification of the Analytical<br>Measurement Range (AMR), and<br>verification of reportable ranges of<br>manual, automated and semi-<br>automated analytical chemistry<br>systems. |
| Number of<br>Analytes per vial | 2 | 2 |
| Number of levels<br>per set | 5 | 5 |
| Contents | 5 x 2 mL | 10 x 3 mL |
| Matrix | Protein-based, liquid | Protein-based, liquid |
| Type of Analytes | Ammonia<br>Ethanol | Ammonia<br>Ethanol |
| Form | Liquid | Liquid |
| Storage | 2 to 8° C<br>Until expiration date | -20° C<br>Until expiration date |
| Open Bottle<br>Stability | 2 days at 2 to 8° C | 2 to 8° C<br>Until expiration date |

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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

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Public Health Service

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

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Re: k100718

> Trade Name: Audit MicroCV Ammonia/Ethano} Linearity Set, Model K712M-5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, Reserved . Product Codes: JJY Dated: August 20, 2010 SEP 8 2010 Received: August 20, 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 Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

signature

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

NewSEltr.

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### Indications for Use

K100718

SEP . 3 2010

510(k) Number: K100718

Device Name: Audit™ MicroCV™ Ammonia/Ethanol Linearity Set

Indications For Use:

"The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol 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)

Division Sign Off

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

510(k) k100718