AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL

K112705 · Aalto Scientific, Ltd. · JJY · Jan 24, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112705
• Device Name: AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human serum -based control for use with assays designed to quantitate: Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoalobulin G (IgG), Immunoqlobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT). Albumin. Complement C4 (C4). Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin. It is intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin assays. 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 the Beckman Immage 800. The Audit® MicroLQ™ Serum Protein Control is for In Vitro Diagnostic use only.

Device Story

Audit® MicroLQ™ Serum Protein Control is a human serum-based, liquid, bi-level quality control material. It contains 16 specific analytes, including various immunoglobulins, complement proteins, and transport proteins. The device is used in clinical laboratories to monitor the precision of quantitative assays performed on the Beckman Immage 800 analyzer. By simulating human patient samples, the control allows laboratory personnel to verify that testing procedures are performing within established acceptable ranges. It does not perform analysis itself; rather, it serves as a reference material to detect systematic analytical deviations. Healthcare providers use the resulting quality control data to ensure the accuracy and reliability of patient test results, thereby supporting clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed on Beckman Immage 800 analyzer using 15 measurements over three days to establish target means. Target ranges calculated as ±15% of target value. Stability established via accelerated stability study (30 days stress) with confirmatory real-time testing ongoing.

Technological Characteristics

Human serum-based liquid control; bi-level; contains 16 analytes (IgE, IgM, IgG, IgA, Prealbumin, Antithrombin III, AAT, Albumin, C4, C3, alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, Beta-2-Microglobulin). Storage at 2-8°C. Open-bottle stability of 36 months at 2-8°C.

Indications for Use

Indicated for use as an assayed, bi-level, human serum-based quality control material to monitor the precision of laboratory testing procedures for 16 specific serum protein analytes (IgE, IgM, IgG, IgA, Prealbumin, Antithrombin III, AAT, Albumin, C4, C3, alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin) on the Beckman Immage 800 analyzer.

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™ Protein Linearity Set (k101216)

Submission Summary (Full Text)

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K112705

Image /page/0/Picture/1 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape at the top, composed of many small dots. Below the triangle, the text "Aalto Scientific, Ltd." is written in a serif font.

510(k) Summary

JAN 2 4 2012

## A. Submitter

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

## B. Contact Person

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

### C. Date of Summary Preparation

January 11, 2012

### D. Device Identification

| Product Trade Name: | Audit® MicroLQT™ Serum Protein Control |
|------------------------|------------------------------------------------------------------------------------------|
| Common Name: | Serum Protein Control |
| Classification Name: | Assay QC Material |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJY |
| | Device to Which Substantial Equivalence is Claimed: |
| Product Trade Name: | Audit® MicroCV™ Protein Linearity Set<br>Aalto Scientific, Ltd., Carlsbad, CA<br>K101316 |

## E. Description of the Device

The Audit® MicroLQ™ Serum Protein Control is a human based, liguid set of QC material. Each level of the set contains Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroclobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin analytes. It is used to confirm the proper calibration of Immunoclobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin.

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Image /page/1/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo consists of a triangle shape made up of small dots, with the letters 'A' and 'S' visible within the triangle. Below the triangle, the text 'Aalto Scientific, Ltd.' is printed in a simple, sans-serif font.

## F. Statement of Intended Use

Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human serum -based control for use with assays designed to quantitate: Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoalobulin G (IgG), Immunoqlobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT). Albumin. Complement C4 (C4). Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin. It is intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin assays. 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 the Beckman Immage 800

The Audit® MicroLQ™ Serum Protein Control is for In Vitro Diagnostic use only.

## G. Summary of Performance Data

Stability studies have been performed to determine the shelf life for the Audit® MicroLQ™ Serum Protein Control Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:

Shelf Life: Three years, when stored unopened 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

| Characteristics | Audit® MicroLQ™ Serum Protein Control Set<br>(K112705) | Audit™ MicroCV™ Protein Linearity Set<br>(K101216) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Audit® MicroLQ™ Serum Protein Control is an<br>assayed, ready-to-use liquid, bi-level, human serum<br>-based control for use with assays designed to<br>quantitate: Immunoglobulin E (IgE), Immunoglobulin<br>M (IgM), Immunoglobulin G (IgG), Immunoglobulin A<br>(IgA), Prealbumin, Antithrombin III, Alpha-1-<br>Antitrypsin (AAT), Albumin, Complement C4 (C4),<br>Complement C3 (C3), alpha-2-Macroglobulin, Alpha-<br>1-Acid Glycoprotein, Ceruloplasmin, Transferrin,<br>Haptoglobin, and Beta-2-Microglobulin. It is intended<br>to simulate human patient samples for the purpose<br>of monitoring the precision of laboratory testing<br>procedures for Immunoglobulin E (IgE),<br>Immunoglobulin M (IgM), Immunoglobulin G (IgG),<br>Immunoglobulin A (IgA), Prealbumin, Antithrombin III,<br>Alpha-1-Antitrypsin (AAT), Albumin, Complement C4<br>(C4), Complement C3 (C3), alpha-2-Macroglobulin,<br>Alpha-1-Acid Glycoprotein, Ceruloplasmin,<br>Transferrin, Haptoglobin, and Beta-2-Microglobulin<br>assays. When used for quality control purposes, it is<br>recommended that each laboratory establish its own<br>means and acceptable ranges and use the values<br>provided only as guides. The product is intended for<br>use with quantitative assays on the Beckman<br>Immage 800<br>The Audit® MicroLQ™ Serum Protein Control is for<br>In Vitro Diagnostic use only. | The Audit™ MicroCV™ Protein Linearity is<br>assayed quality control material consisting of<br>five levels protein (human) based serum. Each<br>level contains Alpha-1-Antitrypsin, Complement<br>C3, Complement C4, Immunoglobulin G,<br>Immunoglobulin A, Immunoglobulin M and<br>Transferrin analytes. The five levels<br>demonstrate a linear relationship to each other<br>for Alpha-1-Antitrypsin, Complement C3,<br>Complement C4, Immunoglobulin G,<br>Immunoglobulin A, Immunoglobulin M, and<br>Transferrin analytes. It is intended to simulate<br>human patient serum samples and to detect<br>systematic analytical deviations of laboratory<br>testing procedures for Alpha-1-Antitrypsin,<br>Complement C3, Complement C4,<br>Immunoglobulin G, Immunoglobulin A,<br>Immunoglobulin M, and Transferrin. The<br>product is intended for use with quantitativ<br>assays on the indicated analyzer provided in<br>the labeling. The Audit MicroCV Protein<br>Linearity Set is "For In Vitro Diagnostic Use<br>Only." |
| Number of Analytes<br>per vial | 16 | 7 |
| Contents | 6 x 2 mL | 5 x 2 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Immunoglobulin E (IgE), Immunoglobulin M (IgM),<br>Immunoglobulin G (IgG), Immunoglobulin A (IgA),<br>Prealbumin, Antithrombin III, Alpha-1-Antitrypsin<br>(AAT), Albumin, Complement C4 (C4), Complement<br>C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid<br>Glycoprotein, Ceruloplasmin, Transferrin,<br>Haptoglobin, and Beta-2-Microglobulin. | Alpha-1-Antitrypsin, Complement C3,<br>Complement C4, Immunoglobulin G,<br>Immunoglobulin A, Immunoglobulin M and<br>Transferrin |
| Form | Liquid | Liquid |
| Storage | 2 to 8° C Until expiration date | 2 to 8° C Until expiration date |
| Open Bottle<br>Stability | 36 months at 2 to 8° C | 24 hours at 2 to 8° C |

## l. Conclusions

Based upon the purpose of the device and the descriptions 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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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

JAN 2 4 2012

Re: k112705

Trade/Device Name: Audit® MicroLQ™ Serum Protein Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I Product Code: JJY Dated: November 22, 2011 Received: November 23, 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 11 Jour de roottols. 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 corply 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

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Page 2 – Ms. Dessi Lyakov

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 nredicate 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 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,

Reena Philip

Maria M. Chan, Ph.D. Director, Division of Immunology and Hematology 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: K112705

Device Name: AUDIT® MicroLQ™ Serum Protein Control

#### Indications For Use:

Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human Adults histor control for use with assays designed to quantitate: Immunoglobulin E (IgE), Scrain Baoou oonliron (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, inindhoglobalin willing sin (ART), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, (OD), alphia E Macroglobulin. It is intended to simulate human patient samples for r haptoglobin, and bota in the grecision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), (192) minin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Prodiburnin, Anaka-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Oomplomorit 00 (00), and Beta-2-Microglobulin assays. When used for quality control rransfermir, huptoglobin, and both ach laboratory establish its own means and acceptable purposes, it is roommended this a may as guides. The product is intended for use with quantitative assays on the Beckman Immage 800.

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)

Division Sitar Off Office of In Vitro

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

510(k) K112705