The Audit™ MicroCV™ RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) 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 manual, automatic, and semi-automatic analyzers. The Audit™ MicroCV™ RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only".

Device Description

The Audit™ MicroCV™ RF/CRP Linearity Set is a 5 level quality control solution set containing C-reactive protein and Rheumatoid Factor as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of RF and CRP. 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

This submission (K101226) is for the Audit™ MicroCV™ RF/CRP Linearity Set, a quality control material used to confirm calibration, linear operating range, and reportable range for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes.

Based on the provided document, the device primarily focuses on demonstrating stability (open-vial and shelf-life) and chemical equivalence to predicate devices, rather than clinical performance against a disease state or diagnosis. As such, the concept of "acceptance criteria" and "device performance" in the traditional sense of diagnostic accuracy (sensitivity, specificity, etc.) with a test set and ground truth established by experts is not directly applicable.

Instead, the acceptance criteria for this device revolve around its stability and its ability to function as a linearity/quality control material. The study therefore focuses on demonstrating these aspects.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core "performance" demonstrated for this device relates to its stability and its intended function as a linearity set.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Reference
Open Vial Stability	All analytes (RF, CRP) stable for 5 days when stored tightly capped at 2-8°C after reconstitution.	All analytes (RF, CRP) demonstrated stability for 5 days when stored tightly capped at 2-8°C.	Stability studies (retained on file at Aalto Scientific, Ltd.)
Shelf Life	Product stable for 19 months when stored at 2-8°C.	Product demonstrated stability for 19 months at 2-8°C. Real-time studies are ongoing to support this claim.	Stability studies (retained on file at Aalto Scientific, Ltd.)
Linearity Demonstration	Five levels should demonstrate a linear relationship to each other for RF and CRP analytes.	Not explicitly quantified in this summary, but the device is designed to demonstrate linearity on analyzers for RF and CRP. This is inherent to its intended use as a "Linearity Set." The predicate devices also have this function.	Not explicitly detailed in this summary
Matrix Compatibility	Human serum-based, compatible with quantitative assays on manual, automatic, and semi-automatic analyzers.	The device is human serum-based and intended for use with quantitative assays on manual, automatic, and semi-automatic analyzers.	Inherent to device description
Composition	Contains RF and CRP analytes at five different levels.	Contains RF and CRP analytes at five levels, with Level A near lower limit and Level E near upper limit, and Levels B-D related by linear dilution.	Inherent to device description

Detailed Information on Studies:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify exact sample sizes (e.g., number of vials, number of runs) for the stability studies. It only states that "Stability studies have been performed."
- The data provenance is internal to Aalto Scientific, Ltd. (USA), as implied by the statement "All supporting data is retained on file at Aalto Scientific. Ltd." The studies are prospective in nature for shelf-life (real-time studies are ongoing) and likely prospective for open-vial stability.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is a quality control material where the "ground truth" is defined by the expected stability parameters (e.g., maintained concentration within a specified range over time) and the linearity of the prepared levels.
- Therefore, the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense, is not applicable. The performance is determined by established analytical methods and specifications, likely overseen by qualified laboratory personnel and chemists/biochemists, rather than clinical experts interpreting results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not a diagnostic device requiring human interpretation or adjudication of results against a clinical ground truth. Performance is assessed through analytical testing against predefined specifications.
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 device is a quality control material, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a biochemical reagent, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" here is the analytical specification and expected behavior of the linearity set. For stability, the ground truth is that the analyte concentrations remain within acceptable limits over time. For linearity, the ground truth is that the five levels will produce a linear response when measured on an appropriate analytical instrument. These are determined by the manufacturer's internal standards and established analytical chemistry principles.
The sample size for the training set:
- Not applicable. This is a quality control material, not a machine learning algorithm that requires a training set. The product is manufactured according to a set formulation and tested for consistency and stability.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary of the Study:

The primary study detailed in the K101226 summary is a stability study. This study demonstrated that the Audit™ MicroCV™ RF/CRP Linearity Set is stable for:

5 days after reconstitution when stored tightly capped at 2-8°C (open vial stability).
19 months when stored unopened at 2-8°C (shelf life).

The summary explicitly states: "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: 19 months at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product."

The design of the product, with five levels demonstrating a linear relationship through dilution, inherently defines its function as a linearity set. The "performance" in this context is its ability to reliably fulfill this function and maintain its properties over time. The submission demonstrates substantial equivalence primarily through comparing its intended use, analytes, matrix, and physical form to existing predicate devices (Bio-Rad Liquichek Lipids Control, Audit™ MicroCV™ General Chemistry Linearity Set, and LiniCAL Calibration Verifier RF/CRP).

Summary

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510(k) Summary

KID1226

A. Submitter

AUG 3 1 2010

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

April 30, 2010

D. Device Identification

Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:

Audit™ MicroCV™ RF/CRP Linearity Set Calibration Verification Multi analyte controls (Assayed and Unassayed) Class I 21 CFR 862.1660 75 JJY

E. Device to Which Substantial Equivalence is claimed

Product Trade Name:

LiniCAL Calibration Verifier RF/CRP CLINIQA, Fallbrook, CA 92028 K023661

Liquichek Lipids Control Bio-Rad Laboratories, Irvine, California K012513

Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318

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F. Description of the Device

G. 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™ RF/CRP 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: 19 months 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	AuditTMMicroCVTMRF/CRPLinearity Set (K101226)	Bio-Rad LiquichekLipids Control(K012513)	AuditTM MicroCVTMGeneral ChemistryLinearity Set (K042318)	LiniCALCalibration VerifierRF/CRP (K023661)
Intended Use	The AuditTMMicroCVTM RF/CRPLinearity Set is anassayed quality controlmaterial consisting offive levels human basedserum. Each levelcontains RheumatoidFactor (RF) and C-Reactive Protein (CRP)analytes. The five levelsdemonstrate a linearrelationship to eachother for RheumatoidFactor (RF) and C-Reactive Protein (CRP)analytes. This productmay also be used asunassayed qualitycontrol material forRheumatoid Factor(RF) and C-ReactiveProtein (CRP) analytes.When used for qualitycontrol purposes, it isrecommended that eachlaboratory establish itsown means andacceptable ranges anduse the values providedonly as guides. Theproduct is intended foruse with quantitativeassays on manual,automatic, and semi-automatic analyzers.The AuditTMMicroCVTM RF/CRPLinearity Set is "For InVitro Diagnostic UseOnly".	Liquichek LipidsControl is intendedfor use as anassayed qualitycontrol serum tomonitor theprecision oflaboratory testingprocedures for thelisted analytes.	Audit® MicroCVTM GeneralChemistry Linearity Setconsists of five levels ofhuman based serum. Eachlevel contains the followinganalytes: Albumin, AlkalinePhosphatase, ALT,Amylase, AST, Bilirubin(Total and Direct), BUN,Calcium, Chloride,Cholesterol, CO2 CreatineKinase, Creatinine, Gamma-GT, Glucose, HDLCholesterol, Iron, Lactate,LDH, LDL Cholesterol,Lipase, Magnesium,Phosphorus, Potassium,Sodium, Total Protein,Triglycerides and Uric Acid.These five levelsdemonstrate a linearrelationship to each other fortheir respective analytes,reagents and instruments1.This product may also beused as unassayed qualitycontrol material for theseanalytes. When used forquality control purposes, itis recommended that eachlaboratory establish its ownmeans and acceptable rangesand use the values providedonly as guides. In addition,it may be used forproficiency testing ininterlaboratory surveys andto perform CLIA directedcalibration verification2 forthese same analytes inaccordance with currentCLIA-88 guidelines andregulations3	LiniCALCalibration VerifierRF/CRP is intendedfor use in theclinical laboratoryto objectively verifycalibration andassess linearityregarding RF andCRP. Five targetedassayed materialsare provided toallow monitoringthe manufacturer'sreportable range.

Number ofAnalytes per vial	2	8	31	2
Number of levelsper set	5	2	5	5
Contents	5 x 1 mL	2 x 3mL	5 x 1mL	5 x 1mL
Matrix	Human Serum	Human Serum	Human Serum	Human Serum
Type of Analytes	C-Reactive ProteinRheumatoid Factor	C-Reactive ProteinApolipoprotein A-1Apolipoprotein BCholesterolHDL CholesterolLDL CholesterolLipoprotein (a)Triglycerides	Albumin, AlkalinePhosphatase, ALT,Amylase, AST, Bilirubin(Total and Direct), BUN,Calcium, Chloride,Cholesterol, CO₂Creatine Kinase.Creatinine, Gamma-GT.Glucose, HDLCholesterol, Iron.Lactate, LDH, LDLCholesterol, Lipase.Magnesium, Phosphorus,Potassium, Sodium,Total Protein,Triglycerides and UricAcid.	Rheumatoid Factor (RF)C-Reactive Protein (CRP)
Form	Liquid	Liquid	Lyophilized	Liquid
Storage	2 to 8° C for 19 months	-20°C to -70°C for 36months	2 to 8° C for 48 months	2 to 8° C for 48 months
Open BottleStability	5 days at 2 to 8° C	14 days at 2 to 8°C	7 days at 2 to 8° C	14 days at 2 to 8°C

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J. SIMILARITIES AND DIFFERENCES between the Audit™

MicroCVTMRF/CRP Linearity Set (K101226) and the Predicate Devices

Similarities between the Audit™ MicroCV™RF/CRP Linearity Set (K101226) and all Predicate Devices:

. All products are human serum based quality control materials intended to monitor the precision of laboratory testing procedures for the listed analytes.
All products were made using the same method of spiking various constituents to . human based matrix.
All products content multiple levels. 트
Audit™ MicroCV™RF/CRP Linearity Set (K101226) and LiniCAL Calibration 트 Verifier RF/CRP (K023661) have the same analytes.

Diferences between the Audit™ MicroCV™RF/CRP Linearity Set (K101226) and all Predicate Devices:

Audit™ MicroCV™RF/CRP Linearity Set (K101226), Bio-Rad Liquichek . Lipids Control (K012513), and LiniCAL Calibration Verifier RF/CRP (K023661) are liquid products Audit™ MicroCV™ General Chemistry Linearity Set (K042318) is lyophilized product.
Audit™ MicroCVTMRF/CRP Linearity Set (K101226), Bio-Rad Liquichek . Lipids Control (K012513), and LiniCAL Calibration Verifier RF/CRP (K023661) have different analytes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

AUG 3 1 2010

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

Re: K101226

Trade/Device Name: Audit™ MicroCV™ RF/CRP 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: August 18, 2010 Received: August 18, 2010

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

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Page 2 - Ms. Dessi Lyakov

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device 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.

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 vours. marrow in chan

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: K101226

Device Name: Audit™ MicroCV™ RF/CRP Linearity Set

Indications For Use:

The Audit™ MicroCV™ RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) 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 manual, automatic, and semi-automatic analyzers. The Audit™ MicroCVTM RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only".

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

AUG 3 1 2010

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510K k10/226

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.