AUDIT MICROLQ SPINAL FLUID CONTROL

K112742 · Aalto Scientific, Ltd. · JJY · Jun 15, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112742
• Device Name: AUDIT MICROLQ SPINAL FLUID CONTROL
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures. 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® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.

Device Story

Audit® MicroLQ™ Spinal Fluid is a human-based, liquid quality control material. It contains 10 analytes: Chloride, Glucose, IgA, IgG, IgM, Lactate, Lactate Dehydrogenase (LD), Microalbumin, Microprotein, and Sodium. Used in clinical laboratories to monitor the precision of testing procedures; helps verify calibration of diagnostic assays. Laboratory personnel use the material to establish internal means and acceptable ranges for test performance. Provides a guide for quality assurance in diagnostic testing; benefits patients by ensuring the accuracy and reliability of clinical laboratory results.

Clinical Evidence

No clinical data. Performance is supported by stability studies confirming a two-year shelf life (unopened at 2-8°C) and 30-day open-vial stability (at 2-8°C).

Technological Characteristics

Human-based serum matrix; liquid form; 10 analytes (Chloride, Glucose, IgA, IgG, IgM, Lactate, LD, Microalbumin, Microprotein, Sodium); stored at 2-8°C; 30-day open-vial stability.

Indications for Use

Indicated for use as an in vitro diagnostic quality control material to monitor the precision of laboratory testing procedures for specific analytes in spinal fluid. No specific patient population is targeted as this is a laboratory control product.

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 (k101216)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '112742'. The numbers are written in a simple, slightly irregular style, typical of handwriting.

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### 510(k) Notification Audit® MicroLQ™ Spinal Fluid

JUN 1 5 2012

#### 510(k) Summary

### 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

June 13, 2012

#### D. Device Identification

| Product Trade Name: | Audit® MicroLQ™ Spinal Fluid |
|------------------------|------------------------------|
| Common Name: | Spinal Fluid |
| 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:

Audit® MicroCV™ Protein Linearity Set Product Trade Name: Aalto Scientific, Ltd., Carlsbad, CA K101216

### E. Description of the Device

The Audit® MicroLQ™ Spinal Fluid is a human based, liquid set of QC material. Each level of the set contains Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium analytes. It is used to confirm the proper calibration of Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium

#### F. Statement of Intended Use

Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the

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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 made up of many small dots, resembling a pyramid or mountain. Below the shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.

## 510(k) Notification Audit® MicroLQ™ Spinal Fluid

precision of laboratory testing procedures.

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® MicroLQ™ Spinal Fluid 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™ Spinal Fluid Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:

Shelf Life: Two years, when stored unopened at 2 - 8º C.

Open Vial: 30 days, when stored at 2 - 8º C.

Note: Real time studies are ongoing to support the shelf life of this product.

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# 510(k) Notification Audit® MicroLQ™ Spinal Fluid

### H. Technical Characteristics Compared to Predicate Device

| Characteristics | Audit® MicroLQ™ Spinal Fluid Set (New Device) | Audit™ MicroCV™ Protein Linearity Set (K101216) |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures.<br>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.<br>The Audit® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only. | Same |
| Number of<br>Analytes per vial | 10 | 7 |
| Contents | 6 x 3 mL | 5 x 5 mL |
| Matrix | Human Based Serum | Same |
| Type of Analytes | Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium | Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin |
| Form | Liquid | Same |
| Storage | 2 to 8º C<br>Until expiration date | Same |
| Open Bottle<br>Stability | 30 days at 2 to 8º C | 24 hours at 2 to 8º |

### 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 oredicate device.

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#### Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

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

JUN 1 5 2012

Re: k112742

> Trade Name: Audit® MicroLQTM Spinal Fluid Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: April 23, 2012 Received: April 25, 2012

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.

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/Medical

Devices/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/Resourcesfor You/Industry/default.htm

Sincerely yours,

Signature

Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology 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: K112742

Device Name: AUDIT® MicroLQ™ Spinal Fluid Control Set

Indications For Use:

Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures.

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® MicroLQ™ Spinal Fluid 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)

ORAL C

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

K 112742 510(k)