The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the Cystatin-C analyte.

The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.

Device Description

The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are 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 based on the provided document:

This document is a 510(k) Premarket Notification for a Linearity LQ Cystatin-C quality control material (device). The goal of the submission is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Study	Acceptance Criteria	Reported Device Performance
Shelf Life (Unopened)	Product claims: 3 years, when stored unopened at 2-8°C.	Accelerated stability studies were conducted to establish the shelf life stability claims. Acceptance criteria were met to support the product claims of 3 years, when stored unopened at 2-8°C. (Real-time studies are ongoing).
Open Vial Stability	Product claims: Once a vial has been opened, the product will be stable for 30 days when stored tightly capped at 2-8°C.	Real-time stability studies conducted at the end of accelerated stability studies. Acceptance criteria were met to support the product claims of 30 days when stored tightly capped at 2-8°C.
Target Ranges for Cystatin-C	Target ranges for each of the 5 levels were calculated as ± 10% of the target value. (Implied: Measured values should fall within these ranges).	The mean value of the Cystatin-C analyte was used to establish target concentration value at each level. The target ranges for Cystatin-C (in mg/L) for each level are:- Level A: 0.584-0.714 (Target 0.649)- Level B: 2.09-2.56 (Target 2.33)- Level C: 3.69-4.51 (Target 4.10)- Level D: 5.08-6.21 (Target 5.65)- Level E: 6.44-7.87 (Target 7.15)
Non-reactivity for Infectious Disease Markers	Human-origin materials used must be tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.	Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

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

This document describes a quality control material used for linearity, calibration verification, and reportable range for a specific analyte (Cystatin-C). It's not a diagnostic device with a "test set" in the traditional sense of patient data.

Test Set Description: The "test set" here refers to the actual device (Linearity LQ Cystatin-C) which comes in five levels (A, B, C, D, E) of a liquid material. Each level contains 1ml.
Sample Size:
- For stability studies: Vials from two lots of finished product were used for real-time stability (stored at 2-8℃ and -80℃). Measurements were taken at two different time points. The analyte values from these vials were tested in duplicate.
- For value assignment: The Cystatin-C analyte was measured multiple times.
Data Provenance: The document does not specify the country of origin of the data. The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA. These are prospective studies performed to characterize the device's stability and assigned values.

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

This type of device (quality control material) does not typically involve human "experts" establishing a ground truth for a test set in the way a diagnostic algorithm for medical images would. Instead, the ground truth (target concentration values) is established through technical laboratory measurements.

Number of Experts: Not applicable.
Qualifications: Not applicable. The "ground truth" (target values) is established through analytical testing methods on a specific instrument.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is not a diagnostic device where patient cases are reviewed and adjudicated. The "ground truth" (target analyte concentrations) for the quality control material is inherent to its formulation and confirmed through laboratory measurements.

5. 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 a quality control material, not an AI-powered diagnostic device, and therefore no MRMC study was conducted or relevant.

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

Not applicable. This is a laboratory quality control material, not an algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for this device, the Audit® MicroControls™ Linearity LQ Cystatin-C, is analytical reference measurement. Specifically:

Analyte Value Assignment: "The mean value of the Cystatin-C analyte was used to establish target concentration value at each level." This refers to the measured concentration on a reference instrument (Beckman Immage) using a specific reagent.
Stability: Measured values at different time points and storage conditions are compared against initial or expected values established through analytical testing.

8. The Sample Size for the Training Set

Not applicable. This is a quality control material, not a machine learning algorithm, and therefore does not have a "training set."

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

Not applicable. As there is no training set for this type of device, the concept of establishing ground truth for it does not apply.

Summary

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

AALTO SCIENTIFIC, LTD. ROBERT BURDA REGULATORY AFFAIRS MANAGER 1959 KELLOGG AVE. CARLSBAD CA 92008

January 23,2015

Re: K143571

Trade/Device Name: Audit® MicroControls™ Linearity LQ Cystatin-C Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: December 12, 2014 Received: December 17, 2014

Dear Mr. Robert Burda:

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 Parts 801 and 809); 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -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) K143571

Device Name

Audit® MicroControls™ Linearity LQ Cystatin-C

Indications for Use (Describe)

The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

A. Submitter

Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6942

Contact Person

Robert Burda Regulatory Affairs Manager Telephone: (760) 431-7922 ext. 134 Email: rburda@aaltoscientific.com

Date of Summary Preparation

December 12, 2014

B. Device Identification

Product Trade Name:	Audit® MicroControls™™ Linearity LQ Cystatin-C
Common Name:	Single (Specified) Analyte Controls, All Kinds (Assayed and Unassayed)
Review Panel:	Clinical Chemistry
Device Classification:	Class I, Reserved
Product Code:	JJX
Regulation Number:	21CFR862.1660

C. Device to Which Substantial Equivalence is Claimed

K130157 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set

D. Intended Use

The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for the Cystatin-C analyte.

The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.

E. Technical Characteristics Compared to Predicate Device

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Characteristics	Audit® MicroControls™Linearity LQ Cystatin-C(New Device)	Audit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set(Predicate Device, K130157)
Intended Use	The Linearity LQ Cystatin-Cis an assayed quality controlmaterial intended to simulatehuman patient samples for usein determining linearity,calibration verification, andthe verification of reportablerange for the Cystatin-Canalyte.The Linearity LQ Cystatin-Cis for In Vitro Diagnostic useonly.	The Audit® MicroCV™Beta-Hydroxybutyric AcidLinearity Set is an assayedquality control materialconsisting of five levels ofhuman based serum. Eachlevel contains Beta-Hydroxybutyric Acid.These five levelsdemonstrate a linearrelationship to each otherfor Beta-HydroxybutyricAcid. It is intended tosimulate human patientserum samples for purposeof determining linearity,calibration verification andverification of reportablerange for Beta-Hydroxybutyric Acid.The product is intended foruse with quantitative assayson the indicated analyzerprovided in the labeling andmay be used as qualitycontrol material for Beta-Hydroxybutyric Acid.When used for qualitycontrol purposes, it isrecommended that eachlaboratory establish its ownmeans and acceptableranges and use the valuesprovided only as guides.The Audit® MicroCV™Beta-Hydroxybutyric AcidLinearity Set should not beused for calibration orstandardization of the Beta-
			Hydroxybutyric Acid assay.The Audit® MicroCVTMBeta-Hydroxybutyric AcidLinearity Set is “For InVitro Diagnostic Use Only”.
Number ofLevels per Set	5		5
Contents	5x1ml		5x1ml
Matrix	Human Based Serum andbovine based serum		Human Based Serum
Type ofAnalytes	Clinical Chemistry		Clinical Chemistry
Form	Liquid		Liquid
Storage	2-8°C		2-8°C
Open VialStability	30 days at 2-8°C		40 days at 2-8°C
Sterile	No		No
Analytes	Cystatin-C		Beta-hydroxybutyric acid
Number ofAnalytes perVial	1		1

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F. Device Description

G. Value Assignment/Linearity

Analyte value assignment for Level A through Level E was performed on Beckman Immage for the Cystatin-C analyte using the corresponding reagent. The Cystatin-C analyte was measured multiple times. The mean value of the Cystatin-C analyte was used to establish target concentration value at each level. All supporting data is retained on file at Aalto Scientific, Ltd.

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0.4-7.5mg/L

H. Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for Audit® MicroControls™ Linearity LQ Cystatin-C.

Shelf Life-Accelerated Stability

Accelerated stability studies were conducted to establish the shelf life stability claims. All supporting data is retained on file at Aalto Scientific, Ltd. Acceptance criteria were met to support the product claims as follows:

Shelf Life: 3 years, when stored unopened at 2-8º C.

Shelf Life-Real Time Stability

Vials from two lots of finished product are stored at 2-8℃ (real time vials) and -80℃ (Dayl) vials). Samples are taken at two different time points. The analyte values from the real time vials are compared to the Day0 vials (both tested in duplicate). The product is determined to meet its predicted shelf life if the % difference of the real time mean values compared to the Day0 mean value is within the acceptance criteria. All supporting data is retained on file at Aalto Scientific, Ltd.

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

Open Vial-Accelerated Stability+Real Time Stability

Real time stability studies were conducted at the end of accelerated stability studies to establish the open vial stability claims. All supporting data is retained on file at Aalto Scientific, Ltd. Acceptance criteria were met to support the product claims as follows:

Open Vial Stability: Once a vial has been opened, the product will be stable for 30 days when stored tightly capped at 2-8° C.

I. Expected Values

Analyte value assignment was performed for Audit® MicroControls™ Linearity LQ Cystatin-C on Beckman Immage using the corresponding reagents for Cystatin-C. Cystatin-C was measured multiple times and the mean value was used to establish target concentration values at each level. The target ranges were calculated as ± 10% of the target value.

All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:

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Cystatin-C (mg/L)/Beckman Immage
Level A		Level B		Level C		Level D		Level E
Target value	Target Range	Target value	Target Range	Target value	Target Range	Target value	Target Range	Target value	Target Range
0.649	0.584-0.714	2.33	2.09-2.56	4.10	3.69-4.51	5.65	5.08-6.21	7.15	6.44-7.87

J. Traceability

Materials are obtained from internally qualified vendors and are subject to an internal quality control process. Raw material information is retained on file at Aalto Scientific, Ltd.

K. Conclusions

Based upon the purpose of the device, the descriptions and labeling of the predicate device, the safety and efficacy, and the stability data generated, the product is substantially equivalent to the predicate device.

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.