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 Description

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

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Audit® MicroLQ™ Spinal Fluid." This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/algorithm-based devices) that your request outlines.

The "studies" mentioned in the document are limited to stability studies performed to determine the shelf life of the quality control material. This is a very different type of study from those typically conducted for AI/algorithm-based diagnostic devices.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design as laid out in your prompt because this information is not present in the provided text. The document is for a quality control material for laboratory testing, not an AI or algorithm-based diagnostic device.

Here's a breakdown of why the information is missing based on the provided text:

Acceptance Criteria and Reported Device Performance (Table): Not applicable in the context of stability studies for a QC material. The "device performance" here is its stability, detailed below.
- Acceptance Criteria (Implicit - based on product claims):
  - Shelf Life: Two years, when stored unopened at 2 – 8º C.
  - Open Vial: 30 days, when stored at 2 – 8º C.
- Reported Device Performance:
  - The document states "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."
  - It also notes: "Real time studies are ongoing to support the shelf life of this product."
Sample Size used for the test set and data provenance: Not relevant for a stability study of a QC material. There is no "test set" in the context of evaluating an algorithm's performance on patient data.
- The document states that "All supporting data is retained on file at Aalto Scientific. Ltd." but doesn't detail the sample size or specific methodology of the stability studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Stability studies do not involve expert interpretation for ground truth.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study is for evaluating human performance with and without AI assistance, which is not relevant for a quality control material.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this device is a quality control material, not an algorithm.
The type of ground truth used: For stability studies, the "ground truth" would be the known concentration of analytes in the QC material over time, measured by analytical methods, not expert consensus, pathology, or outcomes data. The document does not specify how this ground truth was measured or established in detail.
The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a quality control material used to monitor the precision of laboratory tests, not an AI-powered diagnostic device. Therefore, the specific types of studies, acceptance criteria, and ground truth methodologies requested are not relevant or present in this context.

Summary

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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.

Image /page/0/Picture/1 description: The image shows the logo for Aalto Scientific, Ltd. The logo features a stylized triangle composed of many small squares, resembling a mountain or pyramid. Below the triangle, the text "Aalto Scientific, Ltd" is printed in a simple, sans-serif font. The text is arranged on two lines, with "Aalto" on the first line and "Scientific, Ltd" on the second line.

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: (760) 431-7922 Fax: (760) 431-6824

B. Contact Person

Dessi Lyakov Regulatory Affairs Manager Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com

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

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.

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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Image /page/2/Picture/0 description: The image shows a logo with a triangular shape at the top, resembling a mountain or pyramid, composed of many small dots. Below the logo, the text "Aulto Scientific, Ltd" is printed in a simple, sans-serif font. The text is slightly blurred, suggesting the image may be a scan or a low-resolution file.

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.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.	Same
Number ofAnalytes 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 CUntil expiration date	Same
Open BottleStability	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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or (301) 796-5680 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.

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)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.