(36 days)
The Linearity LQ Special Diabetes 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 following analytes: fructosamine, insulin, and C-peptide.
Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.
The Audit® MicroControls™ Linearity LQ Special Diabetes product is an in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material, containing Fructosamine, Insulin, C-peptide and additives in human serum. There are five levels labeled A, B, C, D and E which contain 2ml for each level.
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.
This document describes the 510(k) summary for the Audit® MicroControls™ Linearity LQ Special Diabetes device. This device is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of the reportable range for fructosamine, insulin, and C-peptide.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on the stability (shelf life and open vial stability) and value assignment (expected range) as performance criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Shelf Life Stability | Product claims supported by accelerated stability studies. | 18 months, when stored unopened at 2-8°C. |
| Open Vial Stability | Product claims supported by accelerated + real-time stability studies. | 14 days, when stored tightly capped at 2-8°C, once opened. |
| Value Assignment (Analytes) | Target ranges calculated as +/-15% of the target mean values. | Fructosamine (µmol/L):- Level A: Target 24.10 (Range 20.49-27.72)- Level B: Target 258.25 (Range 219.52-296.99)- Level C: Target 496.44 (Range 421.97-570.91)- Level D: Target 748.14 (Range 635.92-860.36)- Level E: Target 975.70 (Range 829.35-1122.06)Insulin (µU/mL):- Level A: Target 1.37 (Range 1.17-1.58)- Level B: Target 233.78 (Range 198.71-268.85)- Level C: Target 456.20 (Range 387.77-524.63)- Level D: Target 628.08 (Range 533.87-722.29)- Level E: Target 814.79 (Range 692.57-937.00)C-peptide (ng/mL):- Level A: Target 0.32 (Range 0.27-0.37)- Level B: Target 9.27 (Range 7.88-10.66)- Level C: Target 18.22 (Range 15.49-20.96)- Level D: Target 26.96 (Range 22.91-31.00)- Level E: Target 35.37 (Range 30.07-40.68) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Shelf Life - Real Time Stability: Vials from two lots of finished product. Samples taken at 9 months, 18 months, and 19 months.
- Value Assignment/Linearity: Implicitly, the "five levels labeled A, B, C, D and E" of the device itself are the samples for which values are assigned. Each analyte was "measured multiple times" at each level.
- Data Provenance: Not explicitly stated regarding country of origin, but the company is Aalto Scientific, Ltd. in Carlsbad, CA. The context is a 510(k) submission to the US FDA. The studies appear to be prospective as they involve accelerated and real-time stability studies with samples taken over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The "ground truth" for value assignment seems to be established internally by Aalto Scientific, Ltd. through multiple measurements on specific analytical instruments (Roche Modular P and Roche Cobas e411). There is no mention of external experts or their qualifications for establishing these values.
4. Adjudication Method for the Test Set:
This information is not provided. The value assignment appears to be based on "mean value of the analyte," indicating an averaging approach rather than an adjudication among multiple independent assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic quality control material, not a diagnostic imaging or AI-driven interpretative device that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The performance data presented (stability and value assignment) describes the intrinsic characteristics of the linearity material itself when measured on laboratory instruments. This is analogous to a "standalone" assessment of the material's properties without human interpretative intervention beyond operating the instruments and recording results. The device's "performance" is its ability to maintain its target values and linearity, which is assessed directly by analytical measurements.
7. The Type of Ground Truth Used:
The ground truth used for value assignment and stability assessment appears to be analytical measurements obtained from established, FDA-approved methods on specific laboratory instruments (Roche Modular P for Fructosamine, Roche Cobas e411 for Insulin and C-peptide). For stability, the "Day0 vials" serve as the baseline ground truth reference for comparison with real-time samples.
8. The Sample Size for the Training Set:
This information is not applicable as this device is a quality control material and not an AI/ML algorithm that requires a "training set." The materials used for "value assignment" and "stability studies" are the product itself across different levels and time points.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above. There is no training set for this type of device. The ground truth for the device's characteristics (analyte concentrations at each level) is established by multiple analytical measurements on a specified instrument, and the mean value is used.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
AALTO SCIENTIFIC LTD. ROBERT BURDA REGULATORY AFFAIRS MANAGER 1959 KELLOGG AVE. CARLSBAD CA 92008
Re: K142978
Trade/Device Name: Audit Microcontrols Linearity LO Special Diabetes Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: October 15, 2014 Received: October 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.
{1}------------------------------------------------
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.
Courtney H. Lias -S
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K142978
Device Name
Audit® MicroControls™ Linearity LQ Special Diabetes
Indications for Use (Describe)
The Linearity LQ Special Diabetes 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 following analytes: fructosamine, insulin, and C-peptide.
Linearity LQ Special Diabetes 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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
November 18, 2014
B. Device Identification
| Product Trade Name: | Audit® MicroControls™ Linearity LQ Special Diabetes |
|---|---|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
| Review Panel: | Clinical Chemistry and Clinical Toxicology Devices |
| Device Classification: | Class I, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21CFR862.1660 |
C. Device to Which Substantial Equivalence is Claimed
K130157 Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Set
D. Intended Use
The Linearity LQ Special Diabetes 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 following analytes: fructosamine, insulin, and C-peptide.
Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.
{4}------------------------------------------------
| Characteristics | Audit® MicroControls™Linearity LQ Special Diabetes(New Device) | Audit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set(Predicate Device, K130157) |
|---|---|---|
| Intended Use | The Linearity LQ SpecialDiabetes is an assayed qualitycontrol material intended tosimulate human patient samplesfor use in determining linearity,calibration verification, and theverification of reportable rangefor the following analytes:fructosamine, insulin, and C-peptide.Linearity LQ Special Diabetes isfor In Vitro Diagnostic use only. | The Audit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set is an assayedquality control materialconsisting of five levels ofhuman based serum. Eachlevel contains Beta-Hydroxybutyric Acid. Thesefive levels demonstrate alinear relationship to eachother for Beta-Hydroxybutyric Acid. It isintended to simulate humanpatient serum samples forpurpose of determininglinearity, calibrationverification and verificationof reportable range for Beta-Hydroxybutyric Acid.The product is intended foruse with quantitative assayson the indicated analyzerprovided in the labeling andmay be used as quality controlmaterial for Beta-Hydroxybutyric Acid. Whenused for quality controlpurposes, it is recommendedthat each laboratory establishits own means and acceptableranges and use the valuesprovided only as guides. TheAudit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set should not beused for calibration orstandardization of the Beta-Hydroxybutyric Acid assay. |
| Hydroxybutyric AcidLinearity Set is “For In VitroDiagnostic Use Only”. | ||
| Number of Levelsper Set | 5 | 5 |
| Contents | 5x2ml | 5x1ml |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Clinical Chemistry | Clinical Chemistry |
| Form | Liquid | Liquid |
| Storage | 2-8°C | 2-8°C |
| Open VialStability | 14 days at 2-8°C | 40 days at 2-8°C |
| Sterile | No | No |
| Analytes | Fructosamine, insulin, C-peptide | Beta-hydroxybutyric acid |
| Number ofAnalytes per Vial | 3 | 1 |
E. Technical Characteristics Compared to Predicate Device
{5}------------------------------------------------
F. Device Description
The Audit® MicroControls™ Linearity LQ Special Diabetes product is an in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material, containing Fructosamine, Insulin, C-peptide and additives in human serum. There are five levels labeled A, B, C, D and E which contain 2ml for each level.
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.
G. Value Assignment/Linearity
Each analyte value assignment for Level A through Level E was performed on Roche Modular P for Fructosamine, Roche Cobas e411 for Insulin and C-peptide by using the corresponding reagent. Each analyte was measured multiple times. The mean value of the analyte was used to establish the target concentration value at each level. All supporting data is retained on file at Aalto Scientific, Ltd.
AMR Values: Fructosamine 10-1000 umol/L C-peptide: 0.01-40 ng/ml Insulin 0.2-1000 µU/ml
H. Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Audit® MicroControls™ Linearity LQ Special Diabetes.
{6}------------------------------------------------
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: 18 months, when stored unopened at 2-8°C.
Shelf Life-Real Time Stability
Vials from two lots of finished product are stored at 2-8℃ (real time vials) and -80℃ (Day0 vials). Samples are taken from each lot at 9 months, 18 months and 19 months. The analyte values from the real time vials are compared to the Dav() 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 14 days when stored tightly capped at 2-8º C.
I. Expected Values
Value assignment of Audit® MicroControls™ Linearity LQ Special Diabetes have been performed to determine the expected values of the fructosamine, insulin and C-peptide analytes. Each analyte value assignment for Level A through Level E is performed on Roche Modular P for Fructosamine, Roche Cobas e411 for Insulin and C-peptide by using the corresponding reagents. The target ranges were calculated as +/-15% of the target mean values.
All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
| Fructosamine (µmol/L)/Roche Modular P | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 24.10 | 20.49-27.72 | 258.25 | 219.52-296.99 | 496.44 | 421.97-570.91 | 748.14 | 635.92-860.36 | 975.70 | 829.35-1122.06 |
{7}------------------------------------------------
| Insulin (µU/mL) Roche Cobas e411 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 1.37 | 1.17-1.58 | 233.78 | 198.71-268.85 | 456.20 | 387.77-524.63 | 628.08 | 533.87-722.29 | 814.79 | 692.57-937.00 |
| C-peptide (ng/mL)/Roche Cobas e411 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | |||||
| Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange |
| 0.32 | 0.27-0.37 | 9.27 | 7.88-10.66 | 18.22 | 15.49-20.96 | 26.96 | 22.91-31.00 | 35.37 | 30.07-40.68 |
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.
§ 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.