The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification of reportable range for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as 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 Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".

Device Description

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an in-vitro diagnostic device consisting of five levels of Lyophilized linearity material containing Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin and additives in human serum. There are five vials labeled A, B, C, D, and E, and contain 5 mL for each level.

Materials of human origin used in the manufacture of this linearity set has been tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is the demonstration of linearity.

Acceptance Criterion	Reported Device Performance
Five-point linear regression value > 0.90	The study confirms that if the five-point linear regression value is greater than 0.90, and the plots are linear, then the products demonstrate linearity. This indicates that the device's performance met this criterion.
Plots are linear	The study confirms that if the five-point linear regression value is greater than 0.90, and the plots are linear, then the products demonstrate linearity. This indicates that the device's performance met this criterion.

Note: The document explicitly states: "If the five-point linear regression value is greater than 0.90 and if the plots are linear then the products demonstrate linearity." This phrasing indicates these are the conditions for acceptance and that the device met these conditions.

Study Details

This device is an in-vitro diagnostic quality control material, not an AI or imaging device, so many of the requested categories (like MRMC studies, experts for ground truth, adjudication methods, or separate training/test sets for an algorithm) are not applicable in the typical sense. The study focused on demonstrating the linearity of the control material and its stability.

Sample size used for the test set and data provenance:
- Sample Size: Each analyte was measured 5 times (5 separate vials) at each of the five levels (A through E).
- Data Provenance: Not explicitly stated, but implies internal testing by Aalto Scientific, Ltd. The information available does not indicate country of origin for the data (beyond the company location being Carlsbad, CA) or whether it was retrospective or prospective in the context of human patient data. It is a prospective analytical study performed on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a linearity control material. The "ground truth" (target concentration values) was established through repeated measurements on specified instruments (Abbott Axsym and Roche Hitachi 911) using specific reagents. This involves highly trained laboratory personnel but not "experts" in the sense of clinical interpretation for an AI device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The data generation was quantitative measurement. The mean value of five measurements was used to establish the target concentration, which is a statistical method, not an adjudication process.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI or imaging device with human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical quality control material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for each level's concentration was established by mean concentration values from 5 replicate measurements performed on specified laboratory instruments (Abbott Axsym and Roche Hitachi 911) using appropriate reagents. This is effectively an instrument-derived quantitative reference value.
The sample size for the training set:
- Not applicable as there is no "training set" in the context of an algorithm.
How the ground truth for the training set was established:
- Not applicable.

Summary

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510(k) Summarv

A. Submitter

Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824

Contact Person

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

Date of Summary Preparation

April 19, 2013

B. Device Identification

Product Trade Name:	Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set
Common Name:	Audit® MicroCV™ Therapeutic Drug (TDM) Linearity
Review Panel:	Chemistry 75
Classification Names:	Assay QC Material
Device Classification:	Class I, reserved
Product Code:	JJY
Regulation Number:	21 CFR 862.1660

C. Device to Which Substantial Equivalence is Claimed

Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set Aalto Scientific, Ltd. Carlsbad, California

510(k) Number: K082714

D. Device Description:

Materials of human origin used in the manufacture of this linearity set has been tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

Levels	Catalog Number	Configuration------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
י מחירות מש1. U. V. V.	.K707M-F	5 x 5 mL

APR 2 9 2013

K130762

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E. Value Assignment:

All analytes but Lithium value assignment for Levels A through Level E is performed on one Abbatt Axsym instrument by using Abbott reagents. Lithium value assignment for Levels A through Level E is performed on one Roche Hitachi 911 instrument by using Pointe Scientific reagent. Each analyte was measured 5 times (5 separate vials) and the mean value of each analyte was used to establish target concentration values at each level. The target ranges were calculated as ± 15% of the target value. The mean concentration values of each level were plotted (concentration value vs. assigned level) and a linear regression value was obtained. If the five-point linear regression value is greater than 0.90 and if the plots are linear then the products demonstrate linearity.

F. Intended Use:

means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline,

Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".

G. Comparison with predicate

Characteristics	Audit® MicroCV™ Therapeutic Drug(TDM) Linearity Set(Modified)	Audit® MicroCV™ Therapeutic Drug(TDM) Linearity Set(Unmodified-K082714)
Similarities
Intended Use	Linear, calibration verification qualitycontrol material	Linear, calibration verification qualitycontrol material
Number of levelsper set	5	5
Contents	5 x 5 mL	5 x 5 mL

Similarities and differences between new and predicate devices

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Matrix	Human Based Serum	Human Based Serum
Type of Analytes	Clinical Chemistry	Clinical Chemistry
Form	Lyophilized	Lyophilized
Preservatives	Sodium Azide	Sodium Azide
Storage	2 to 8º Cfor 24 months	2 to 8º Cfor 24 months
Open VialStability	7 days at 2 to 8º C	7 days at 2 to 8º C
Sterile	No	No
	Differences
Number ofAnalytes per vial	15	14
Analytes	Acetaminophen, Amikacin,Carbamazepine, Digoxin,Gentamicin, Lithium, Methotrexate,Phenobarbitol, Pheytoin, Quinidine,Salicylate, Theophylline,Tobramycin, Valporic Acid andVancomycin	Acetaminophen, Amikacin,Carbamazepine, Digoxin,Gentamicin, Methotrexate,Phenobarbitol, Pheytoin,Quinidine, Salicylate,Theophylline, Tobramycin, ValporicAcid and Vancomycin

H. Statement of Supporting data:

Stability studies have been performed to determine the open vial stability and shelf life for the Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows: Open Vial Stability: 7 days at 2 - 8º C. Shelf-life Stability: 24 months at 2 - 8º C.

l. Conclusion:

Based upon the performance characteristics indicated above, Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is substantially equivalent to the predicate device K082714.

All supporting data is retained on file at Aalto Scientific, Ltd.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol featuring three curved lines that resemble a human figure in motion or a flowing ribbon-like design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2013

Aalto Scientific, Ltd. C/O Dessi Lyakov 1959 Kellogg Ave. CARLSBAD CA 92008

Re: K130762_

Trade/Device Name: Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJY Dated: March 19, 2013 Received: March 29, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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Page 2- Dessi Lyakov

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industrv/default.htm. .

Sincerely yours,

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130762

Device Name: Audit® MicroCV™TherapeuticDrug (TDM)LinearitySet

Indications For Use:

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Cheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin.

acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".

Prescription Use X AND/OR

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Yung W. Chan -S

Division Sign - Off Office of In Vitro Devices and Radiologic Health

510(k): K130762

Page 1 of 1

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.