The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration, and the verification of reportable range for the glucose analyte.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.

Device Description

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic device consisting of sets of 5 levels of liquid, linearity material and additives in human based serum. The product contains the following analyte: glucose. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. 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 for the Audit® MicroControls™ Linearity DROP LQ Blood Glucose device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria for stability claims rather than performance metrics like sensitivity or specificity.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Met
Shelf Life	2 years, when stored unopened at 2-8º C	Met
Open Vial Stability	7 days, when stored tightly capped at 2-8º C	Met

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

The document mentions that multiple measurements were taken for the analyte at each level during value assignment and stability studies. However, specific sample sizes for a "test set" (e.g., number of unique samples or runs for a formal validation study) are not explicitly provided.
Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. The data is retrospective for the completed accelerated stability study and real-time open vial stability, and prospective for the ongoing real-time shelf-life study. The country of origin of the data is not explicitly stated but can be inferred as the USA, where Aalto Scientific, Ltd. is located.

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

This information is not applicable in the context of this device. The device is a quality control material used to verify the linearity, calibration, and reportable range of blood glucose measurement systems. The "ground truth" for this type of device is established through analytical value assignment based on measurements performed on a reference instrument, not through human expert interpretation of results.
The document states: "Analyte value assignment for Level A through Level E was performed on Roche Cobas for the blood glucose analyte using the corresponding reagent. The analyte was measured multiple times. The mean value of the analyte was used to establish a target concentration value at each level."

4. Adjudication Method for the Test Set

Not applicable. As the device is a quality control material and "ground truth" is established through analytical measurement, there is no human-based adjudication process for a test set in the conventional sense. The "adjudication" is inherent in the analytical measurement and statistical determination of mean values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where human readers are making diagnoses. The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is a quality control material for analytical instruments, not an interpretative device.

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

Not applicable. This device is a control material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm's accuracy without human intervention is not relevant. Its performance is measured by its stability and its ability to produce expected values when analyzed by a blood glucose measurement system.

7. The Type of Ground Truth Used

The ground truth (or target values) for the device's glucose levels was established through analytical measurement on a reference instrument (Roche Cobas c501) with multiple measurements and calculation of the mean value. This is essentially an instrument-based reference value rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not explicitly stated and not directly applicable as this is a physical control material, not an AI/ML algorithm. The concept of a "training set" is typically used for machine learning models. For this device, the equivalent would be the data used for the "value assignment" to establish its target concentrations. The document mentions "The analyte was measured multiple times" for value assignment, but a specific number is not given.

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

As explained in Point 7, the "ground truth" (target values) for the device's five levels (A-E) was established through repeated analytical measurements of the glucose analyte on a Roche Cobas c501 instrument. The mean of these multiple measurements was used to define the target concentration value for each level. Raw materials are subject to internal quality control.

Summary

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

August 10, 2016

AALTO SCIENTIFIC, LTD. ROBERT BURDA REGULATORY AFFAIRS DIRECTOR 230 TECHNOLOGY PARKWAY EATONTON GA 30642

Re: K161874

Trade/Device Name: Audit® MicroControls™ Linearity Drop LQ Blood Glucose Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: July 7, 2016 Received: July 8, 2016

Dear 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) K161874

Device Name

Audit® MicroControls™ Linearity DROP LQ Blood Glucose

Indications for Use (Describe)

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, callbration, and the verification of reportable range for the glucose analyte.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose 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 K161874

A. Submitter

Aalto Scientific, Ltd. 230 Technology Parkway Eatonton, GA 31024 Telephone: (760) 431-7922 (760) 431-6942 Fax:

Contact Person

Robert Burda Regulatory Affairs Director Telephone: (760) 444-8756 Email: rburda@aaltoscientific.com

Date of Summary Preparation

August 05, 2016

B. Device Identification

Product Trade Name:	Audit® MicroControls™ Linearity DROP LQ BloodGlucose
Common Name:	Single (Specified) Analyte Controls (Assayed andUnassayed)
Review Panel:	Clinical Chemistry
Device Classification:	Class I, Reserved
Product Code:	JJX
Regulation Number:	21CFR862.1660

C. Device to Which Substantial Equivalence is Claimed

K130762: Audit® MicroCV ™ Therapeutic Drug (TDM) Linearity Set

D. Intended Use

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration verification, and the verification of reportable range for the glucose analyte.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.

E. Technical Characteristics Compared to Predicate Device

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Characteristics	(New Device)Audit® MicroControls™Linearity DROP LQ BloodGlucose	(Predicate Device, K130762)Audit® MicroCV™Therapeutic Drug (TDM)Linearity Set
Intended Use	The Audit® MicroControls™Linearity DROP LQ BloodGlucose is intended tosimulate human patientsamples for use as assayedquality control material,determining linearity,calibration verification, andthe verification of reportablerange for the glucose analyte.The Audit® MicroControls™Linearity DROP LQ BloodGlucose is for In VitroDiagnostic use only.	The Audit® MicroCV™Therapeutic Drug (TDM)Linearity Set is an assayedquality control materialconsisting of five levels ofhuman based serum. Eachlevel contains:Acetaminophen, Amikacin,Carbamazepine, Digoxin,Gentamicin, Lithium,Methotrexate, Phenobarbital,Phenytoin, Quinidine,Salicylate, Theophylline,Tobramycin, Valproic Acidand Vancomycin. These fivelevels demonstrate a linearrelationship to each other fortheir respective analytes. It isintended to simulate humanpatient serum samples forpurpose of determininglinearity, calibrationverification and verification ofreportable range forAcetaminophen, Amikacin,Carbamazepine, Digoxin,Gentamicin, Lithium,Methotrexate, Phenobarbital,Phenytoin, Quinidine,Salicylate, Theophylline,Tobramycin, Valproic Acidand Vancomycin. Theproduct is intended for usewith quantitative assays onthe indicated analyzerprovided in the labeling andmay be used as qualitycontrol material for theseanalytes. When used forquality control purposes, it isrecommended that eachlaboratory establish its ownmeans and acceptableranges and use the valuesprovided only as guides. TheAudit® MicroCV™

		Therapeutic Drug (TDM)Linearity Set should not beused for calibration orstandardization of theAcetaminophen, Amikacin,Carbamazepine, Digoxin,Gentamicin, Lithium,Methotrexate, Phenobarbital,Phenytoin, Quinidine,Salicylate, Theophylline,Tobramycin, Valproic Acidand Vancomycin assays.The Audit® MicroCV™Therapeutic Drug (TDM)
		Linearity Set is "For In Vitro
		Diagnostic Use Only".
Matrix	Human Serum	Human Serum
Type ofAnalytes	Clinical Chemistry	Clinical Chemistry
Form	Liquid	Freeze-dried powder
Storage	2-8°C	2-8°C
Shelf Life	2 years at 2-8°C	2 years at 2-8°C
Open VialStability	7 days at 2-8°C	7 days at 2-8°C
Sterile	No	No
Analytes	Glucose	Acetaminophen, amikacin,carbamazepine, digoxin,gentamicin, lithium,phenobarbital, phenytoin,quinidine, salicylate,theophylline, tobramycin,valproic acid, andvancomycin

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F. Device Description

G. Value Assignment/Linearity

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The mean and expected range for each method shall be presented in each lot specific insert of Audit® MicroControls™ Linearity DROP LQ Blood Glucose. The indicated values shall be derived from analysis of vials representative of the entire lot. Analyte value assignment for Level A through Level E was performed on Roche Cobas for the blood glucose analyte using the corresponding reagent. The analyte was measured multiple times. The mean value of the analyte was used to establish a target concentration value at each level. All supporting data is retained on file at Aalto Scientific, Ltd.

H. Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Audit® MicroControls™ Linearity DROP LQ Blood Glucose.

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

Shelf Life-Real Time Stability

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

Open Vial Stability

Real time stability studies were conducted 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 7 days when stored tightly capped at 2-8º C.

. Expected Values

Analyte value assignment was performed for Audit® MicroControls™ Linearity DROP LQ Blood Glucose using the corresponding reagents for blood glucose. The analyte was measured multiple times and the mean value was used to establish target concentration values at each level. The target ranges are shown below.

The expected range of the mean is provided to assist the laboratory until it has established its own mean and standard deviation. The indicated mean and expected range (target range) of the mean is provided to serve only as a guide in assessing the performance of the test method in laboratories.

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Approximate target values for glucose are given in the table below. Lot-specific target values may differ after value assignment.

Glucose (mg/dL)/Roche Cobas c501
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
10.7	8.5-12.8	231.0	184.8-277.2	454.7	363.7-545.6	661.5	529.2-793.8	858.0	686.4-1029.6

Levels B, C and D produced according to the following dilution scheme:

Level B = 0.75(Level A) + 0.25(Level E)

Level C = 0.5(Level A) + 0.5(Level E)

Level D = 0.25(Level A) + 0.75(Level E)

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.