AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET

K130157 · Aalto Scientific, Ltd. · JJX · Mar 19, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130157
• Device Name: AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta-Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta-Hydroxybutyric Acid. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. 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 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".

Device Story

Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set consists of five levels of human-based serum containing Beta-Hydroxybutyric Acid; levels are related by linear dilution. Used in clinical laboratories to verify linearity, calibration, and reportable range of quantitative Beta-Hydroxybutyric Acid assays on specified analyzers. Product serves as quality control material; not for calibration or standardization. Laboratory personnel use the provided target values as guides to establish their own acceptable ranges. Benefits include ensuring instrument accuracy and reliability for patient testing.

Clinical Evidence

Bench testing only. Stability studies were performed to determine open vial stability (40 days at 2-8°C) and shelf life (two years at 2-8°C). No clinical data provided.

Technological Characteristics

Assayed quality control material; human-based serum matrix; liquid form; 5 levels per set; 1 analyte per vial. Storage at 2-8°C. No electronic, software, or mechanical components.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient serum for determining linearity, calibration verification, and reportable range verification of Beta-Hydroxybutyric Acid quantitative assays 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.

Submission Summary (Full Text)

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K130157

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

#### MAR 1 9 2013 510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set

# 510(k) Summarv

## A. Submitter

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

## B. Contact Person

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

## C. Date of Summary Preparation

February 15, 2013

#### D. Device Identification

| Product Trade Name: | Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Se |
|----------------------------------------------------|--------------------------------------------------------|
| Common Name: | Beta-Hydroxybutyric Acid Linearity |
| Classification Name: | Assay QC Material |
| Device Classification: | Class I, reserved |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJX |
| Device to Which Substantial Equivalence is Claimed | |
| Product Trade Name: | Audit® MicroCVTM hs-CRP Linearity Set |
| | Aalto Scientific, Ltd., Carlsbad, CA |
| | K101427 |

#### E. Description of the Device

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. 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.

## F. Statement of Intended Use

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta-Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for

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# 510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set

Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta-Hydroxybutvric Acid,

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. 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 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".

# G. Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Audit® MicroCV™ Beta-Hydroxybutyric Acid 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, the Beta-Hydroxybutyric Acid will be stable for 40 days when stored tightly capped at 2 - 8º C.

Shelf Life: Two years, when stored unopened at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product.

# H. Expected Values

Value assignment of Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set have been performed to determine the expected values of Beta-Hydroxybutyric Acid analyte. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:

| Beta-Hydroxybutyric Acid, mmol/L, P-Modular Instrument, Roche Reagent | | | | | | | | | |
|-----------------------------------------------------------------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|
| Level A | Level B | Level C | Level D | Level E | | | | | |
| Target value | Target Range | Target value | Target Range | Target value | Target Range | Target value | Target Range | Target value | Target Range |
| 0.0 | 0.0 | 1.2 | 1.0-1.4 | 2.3 | 2.0-2.6 | 3.4 | 2.9-3.9 | 4.4 | 3.8-5.1 |

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# 510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set

| Characteristics | Audit® MicroCV™ Beta-Hydroxybutyric Acid<br>Linearity Set<br>(New) | Audit™ MicroCV™ hs-CRP<br>Linearity Set<br>(K101427) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit® MicroCV™ Beta-Hydroxybutyric Acid<br>Linearity Set is an assayed quality control material<br>consisting of five levels of human based serum.<br>Each level contains Beta-Hydroxybutyric Acid.<br>These five levels demonstrate a linear relationship<br>to each other for Beta-Hydroxybutyric Acid. It is<br>intended to simulate human patient serum<br>samples for purpose of determining linearity,<br>calibration verification and verification of<br>reportable range for Beta-Hydroxybutyric Acid.<br>The product is intended for use with quantitative<br>assays on the indicated analyzer provided in the<br>labeling and may be used as quality control<br>material for Beta-Hydroxybutyric Acid. When used<br>for quality control purposes, it is recommended<br>that each laboratory establish its own means and<br>acceptable ranges and use the values provided<br>only as guides. The Audit® MicroCV™ Beta-<br>Hydroxybutyric Acid Linearity Set should not be<br>used for calibration or standardization of the Beta-<br>Hydroxybutyric Acid assay. The Audit® MicroCV™<br>Beta-Hydroxybutyric Acid Linearity Set is "For In<br>Vitro Diagnostic Use Only". | The Audit™ MicroCV™ hs-CRP Linearity Set<br>is assayed quality control material consisting<br>of five levels human based serum. Each<br>level contains High Sensitivity C-Reactive<br>Protein (hs -CRP) analyte. The five levels<br>demonstrate a linear relationship to each<br>other for High Sensitivity C-Reactive Protein<br>(hs -CRP) analyte. It is intended to simulate<br>human patient serum samples for purpose of<br>monitoring and detecting systematic<br>analytical deviations of laboratory testing<br>procedures for High Sensitivity C-Reactive<br>Protein (hs -CRP). This product may be used<br>as quality control material for High Sensitivity<br>C-Reactive Protein (hs -CRP) analyte. When<br>used for quality control purposes, it is<br>recommended that each laboratory establish<br>its own means and acceptable ranges and<br>use the values provided only as guides. The<br>product is intended for use with quantitative<br>assays on the indicated analyzer provided in<br>the labeling, The Audit™ MicroCV™ hs-CRP<br>Linearity Set is "For In Vitro Diagnostic Use<br>Only". |
| Number of<br>Analytes per vial | 1 | 1 |
| Number of<br>levels per set | 5 | 5 |
| Contents | 5 x 1 mL | 5 x 1 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Beta-Hydroxybutyric Acid | High Sensitivity C-Reactive Protein |
| Form | Liquid | Liquid |
| Storage | 2 to 8 ° C<br>Until expiration date | 2 to 8 ° C<br>Until expiration date |
| Open Vial<br>Stability | 40 days at 2 to 8 ° C | 20 days at 2 to 8 ° C |

# I. Technical Characteristics Compared to Predicate Device

## 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized representation of a human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the logo in a circular fashion.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### March 19, 2013

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

Re: k130157

Trade/Device Name: Audit ® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJX Dated: January 14, 2013 Received: February 06, 2013

Dear Dessi 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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Page 2- Dessi Lyakov

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: k130157

Device Name: Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set

Indications for Use:

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. 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 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung WOChan-S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k130157