The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.

This product may also be used as a quality control material for these analytes. 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 automatic analyzers. The Audit™ Free T4 / Free T3 Linearity Set is "For In Vitro Diagnostic Use Only".

Device Description

The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set is a 5 level quality control solution set containing Free T4 / Free T3 analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of Free T4 / Free T3 analytes. 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.

AI/ML Overview

The provided text describes the Audit™ MicroCV™ Free T4 / Free T3 Linearity Set, a quality control solution set. The primary study presented focuses on the stability of this device, rather than a clinical performance study involving human readers or comparative effectiveness for diagnostic tasks.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Open Vial Stability	5 days when stored tightly capped at 2-8°C.
Shelf Life	24 months at 2 - 8°C.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for the stability studies. The product has 5 levels (A-E), each containing Free T4 and Free T3 analytes, but the number of aliquots or replicates tested is not provided.
Data Provenance: The studies were performed at Aalto Scientific, Ltd. The text does not specify the country of origin of the data beyond this. The studies are described as "Real time studies are ongoing to support the shelf life," implying they are prospective for shelf-life, and likely involve experimental data generated in a lab setting rather than retrospective patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable to this submission. The device is a linearity set for calibration verification and quality control, not a diagnostic device that requires expert interpretation of results to establish ground truth for a test set. The 'ground truth' for this device would be the expected concentrations and their linear relationship, established through analytical methods.

4. Adjudication Method for the Test Set

This question is not applicable. There's no mention of an adjudication process, as the device doesn't involve subjective interpretations that would require expert consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and an AI's assistance is being evaluated. The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set is an in vitro diagnostic quality control material, not a diagnostic imaging or data interpretation system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of an algorithm or AI. The "device" here is a physical reagent set. The performance is assessed by its chemical and physical stability, which are intrinsic properties of the material and do not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for the stability studies would be analytical measurements of the Free T4 and Free T3 analyte concentrations over time and under specified storage conditions. The stability is determined by comparing these measured values against pre-defined acceptance limits for changes in concentration, or maintenance of linearity, which indicates the product's integrity. The text states, "It is used to confirm the proper calibration, linear operating range, and reportable range of Free T4 / Free T3 analytes." This implies the "ground truth" is adherence to these established analytical parameters.

8. The Sample Size for the Training Set

This concept is not applicable. The device is a linearity set for quality control, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This concept is not applicable, as there is no training set for an AI/ML algorithm.

Summary

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1103601

JUN 1 0 2011

510(k) Summary

A. Submitter

Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: Fax: (760) 431-6824

B. Contact Person

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

C. Date of Summary Preparation

June 7, 2011

D. Device Identification

Product Trade Name:	Audit™ MicroCV™ Free T4 / Free T3 Linearity Set
Common Name:	Calibration Verification
Classification Name:	Multi analyte controls (Assayed and Unassayed)
Device Classification:	Class I
Regulation Number:	21 CFR 862.1660
Panel:	75
Product Code:	JJY

E. Legally marketed (unmodified) device

Product Trade Name:

Audit MicroCV Free T4 / Free T3 Linearity Set Aalto Scientific, Ltd., Carlsbad, California K062668

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F. Description of the Modified Device

Statement of Intended Use

I. Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ Free T4 / Free T3 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, all analytes will be stable for 5 days when stored tightly capped at 2-8 C.

Shelf Life: 24 months 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 Unmodified Device

Characteristics	Audit™ MicroCV™Free T4 / Free T3 Linearity SetK103601	Audit™ MicroCV™Immunoassay Linearity SetK062668
Intended Use	The Audit™ MicroCV™ Free T4 / FreeT3 Linearity Set consists of five levelsof human and bovine albumin basedmatrix. Each level contains thefollowing analytes: Free T4 and FreeT3. The five levels demonstrate alinear relationship to each other fortheir respective analytes, reagents,and instruments.This product may also be used as aquality control material for theseanalytes. When used for quality controlpurposes, it is recommended that eachlaboratory establish its own meansand acceptable ranges and use thevalues provided only as guides. Theproduct is intended for use withquantitative assays on automaticanalyzers. The Audit™ Free T4 / FreeT3 Linearity Set is "For In VitroDiagnostic Use Only".	Audit™ MicroCV™ ImmunoassayLinearity Set is assayed quality controlmaterial consisting of human Albuminbased serum. It is intended to simulatehuman patient serum samples for thepurpose of monitoring the precisionand to detect systematic analyticaldeviations of laboratory testingprocedures. This product may also beused as unassayed quality controlmaterial for these same analytes andmay be used for proficiency testing ininterlaboratory surveys. In addition,this product may also be used toperform CLIA directed calibrationverification for these same analyteswith similar reagents on similarinstrumentation in accordance withcurrent CLIA-88 guidelines andregulations.
Number of levels per set	5	5
Contents	5 x 5mL	5 x 5mL
Matrix	Human and Bovine Albumin Serum	Human and Bovine Albumin Serum
Type of Analytes	Free T4 and Free T3	Cortisol, Digoxin, Estradiol, Ferritin,Folate, Free T4, FSH, hCG, LH,Progesterone, Prolactin, Testosterone,Total PSA, Total T3, Total T4, TSH,and Vitamin B12.
Form	Lyophilized	Lyophilized
Storage	2 to 8º C for 24 months	2 to 8º C for 24 months
Open Bottle Stability	5 days at 2 to 8° C	5 days at 2 to 8° C

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J. Conclusions

Based upon the purpose of the device, the descriptions and labeling of the unmodified device, the safety and efficacy, the risk analyses, and the stability data generated, the modified product is practically identical to the unmodified device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

JUN 1 0 2011

Re: K103601

Trade/Device Name: Audit™ MicroCV™ FreeT4/FreeT3 Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I. reserved Product Code: JJY Dated: 24 March, 2011 Received: 29 March, 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 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). 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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Page 2 --

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Enclosure

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Indications for Use

510(k) Number: K103601

Device Name: Audit™ MicroCV Free T4 / Free T3 Linearity Set

Indications For Use:

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)

Carol C. Benam

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

510(k) K103601

Page 1 of 26

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.