AUDIT MICROCV PROCALCITONIN LINEARITY

K101434 · Aalto Scientific, Ltd. · MJX · Jul 22, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101434
• Device Name: AUDIT MICROCV PROCALCITONIN LINEARITY
• Applicant: Aalto Scientific, Ltd.
• Product Code: MJX · Clinical Chemistry
• Decision Date: Jul 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte. Prescription use only.

Device Story

Audit™ MicroCV™ Procalcitonin Linearity Set is a lyophilized, five-level quality control material containing Procalcitonin in a bovine serum albumin matrix. Designed for use in clinical laboratories to verify calibration, linear operating range, and reportable range of Procalcitonin assays on the Mini-VIDAS BioMerieux instrument. Levels A through E are prepared via linear dilution; Level A represents the lower limit and Level E the upper limit of the instrument's analytical range. Laboratory technicians reconstitute the material with deionized water and process it alongside patient samples. The resulting measurements allow clinicians to monitor assay precision and identify systematic analytical deviations, ensuring the accuracy of Procalcitonin testing used in clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Linearity was established by measuring 8 vials per level and performing linear regression (R² > 0.95). Stability was validated via accelerated heat stress testing (37°C for 10 days) and real-time studies, confirming a one-year shelf life and 5-day open-vial stability at 2-8°C, with results within ±15% of Day Zero values.

Technological Characteristics

Lyophilized bovine serum albumin matrix; contains Procalcitonin analyte; 5-level set; preserved with sodium azide; stored at 2-8°C; 5-day open vial stability.

Indications for Use

Indicated for use as an assayed quality control material to monitor precision and detect systematic analytical deviations in laboratory testing procedures for Procalcitonin. Intended for use with the Mini-VIDAS BioMerieux instrument.

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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K1014634

510(k) Summary

A. Submitter

**FDA CDRH DMC**

JUL 22 2010

Received

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

#### B. Contact Person

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

## C. Date of Summary Preparation

May 18, 2010

#### D. Device Identification

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

Audit™ MicroCVTM Procalcitonin Linearity Set Procalcitonin Linearity Assay QC Material Class I 21 CFR 862.1660 83 MJX

## E. Device to Which Substantial Equivalence is Claimed

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

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### F. Description of the Device

The Audit™ MicroCV™ Procalcitonin Linearity Set is a bovine serum albumin, freeze dried, five level set of QC material, with each level containing one analyte: Procalcitonin. It is used to confirm the proper calibration, linear operating range, and reportable range of Procalcitonin. 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™ Procalcitonin Lincarity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.

#### I. Summary of Performance Data

Stability studies have been performed to determine the shelf life for the Audit™ MicroCVTM Procalcitonin 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, Procalcitonin analyte will be stable for 5 days when stored tightly capped at 2-8 C.

· Shelf Life: One year 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 Predicate Device

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| Characteristics | Audit™ MicroCV™ Procalcitonin<br>Linearity Set<br>(New Device) | Audit™ MicroCV™ General Chemistry<br>Linearity Set<br>(K042318) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit™ MicroCV™ Procalcitonin<br>Linearity Set is assayed quality control<br>material consisting of five levels of<br>Procalcitonin analyte in bovine serum<br>albumin. The five levels demonstrate a<br>linear relationship to each other for the<br>Procalcitonin analyte. It is intended to<br>simulate human patient serum samples<br>for the purpose of monitoring the<br>precision and to detect systematic<br>analytical deviations of laboratory testing<br>procedures for Procalcitonin. This<br>product may be used as an assayed<br>quality control material for Procalcitonin<br>analyte. | Audit™ MicroCV™ General Chemistry<br>Linearity Set is assayed quality control<br>material consisting of human based<br>serum. It is intended to simulate human<br>patient serum samples for the purpose of<br>monitoring the precision and to detect<br>systematic analytical deviations of<br>laboratory testing procedures. This<br>product may also be used as unassayed<br>quality control material for these same<br>analytes. |
| Number of<br>Analytes per vial | 1 | 30 |
| Number of levels<br>per set | 5 | 5 |
| Contents | 5 x 1 mL | 5 x 5 mL |
| Matrix | Bovine Serum Albumin | Human Based Serum |
| Type of Analytes | Clinical Chemistry | General Chemistry |
| Form | Lyophilized | Lyophilized |
| Stabilizers | None | None |
| Preservatives | Sodium azide | Sorbitol<br>Sodium azide |
| Storage | 2 to 8° C<br>Until expiration date | 2 to 8° C<br>Until expiration date |
| Open Vial<br>Stability | 5 days at 2-8 C | 7 days at 2 to 8° C except for enzymes<br>and bilirubin |

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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 cquivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

JUL 2 2 2010

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

Re: k101434

Trade/Device Name: Audit™Micro CV™Procalcitonin Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: MJX Dated: May 21, 2010 Received: May 24, 2010

Dear Mr. 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 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 Parts 801 and 809); medical device 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. This letter will allow you to begin marketing your device as described in your Section

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Page 2 - Dessi Lyakov

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. This letter will allow you to begin marketing your device as described in your Section 1030. This letter will and in your 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 advice for your device on our labeling regulation (21 CFR Part 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,

Sally atzps

Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices 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): unknown k 1614 3 4

Device Name: Audit™ MicroCV™ Procalcitonin Linearity Set

Indications For Use:

The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine scrum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.

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)

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Division Sign-Off

Office of In Vitro Dlagnos Device Evaluation and Safety

510k