(55 days)
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid.
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 Beta-Hydroxybutyric Acid. 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™ Beta- Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta- Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. 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.
The provided document is a 510(k) Summary for a medical device (Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set), which describes the device's intended use, performance data, and comparison to a predicate device. It is a regulatory submission, not a study report that details the methodology and results of a device's performance against specific acceptance criteria in the manner requested.
Therefore, many of the specific details for acceptance criteria and the study that proves the device meets them, especially those pertaining to clinical performance with human readers, ground truth establishment for AI models, and comparative effectiveness studies, cannot be extracted directly from this document. This document is focused on the analytical performance of a quality control material rather than the clinical performance of a diagnostic device.
However, I can extract the information relevant to the analytical performance as described in the document.
Here's an analysis based on the provided text:
Device: Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
Device Type: Assayed quality control material for Beta-Hydroxybutyric Acid.
Purpose: To confirm proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid assays.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides "Product claims" based on stability studies and expected values. These claims serve as the performance characteristics. Explicit "acceptance criteria" for linearity or other analytical parameters are not detailed in this summary, but the "Target Range" for expected values implicitly reflects acceptable performance for value assignment.
| Performance Characteristic | Acceptance Criteria (Implicit from "Product Claims") | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Stable for 40 days when stored tightly capped at 2 - 8° C | Stable for 40 days at 2 - 8° C |
| Shelf Life | Two years, when stored unopened at 2 - 8° C | Two years, when stored unopened at 2 - 8° C (Note: Real time studies ongoing) |
| Expected Values (B-HB, mmol/L) | Within specified Target Ranges for each level | |
| Level A (Target Value) | 0.0 (Target Range) | 0.0 |
| Level B (Target Value) | 1.2 (Target Range: 1.0-1.4) | 1.2 |
| Level C (Target Value) | 2.3 (Target Range: 2.0-2.6) | 2.3 |
| Level D (Target Value) | 3.4 (Target Range: 2.9-3.9) | 3.4 |
| Level E (Target Value) | 4.4 (Target Range: 3.8-5.1) | 4.4 |
Note: The document states, "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." This indicates that the "Target Range" is a guide for expected values, and laboratories would define their specific acceptance criteria based on their analytical system.
Regarding the study that proves the device meets acceptance criteria:
The document refers to "Stability studies" and "Value assignment" studies. These are analytical studies, not clinical studies.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "five levels of human based serum" for the linearity set. For stability studies, the number of samples or experimental replicates is not provided.
- Data Provenance: Not explicitly stated for the test data (e.g., country of origin). The material itself is "human based serum." The studies were performed by Aalto Scientific, Ltd. in Carlsbad, CA, US, suggesting the data originates there.
- Retrospective/Prospective: Not specified, but stability studies typically involve prospective real-time testing, while value assignment could be either.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a quality control material for analytical assays, not a diagnostic device requiring expert interpretation of clinical data. The "ground truth" here is the assigned analytical value of Beta-Hydroxybutyric Acid.
4. Adjudication method for the test set
- Not applicable for this type of analytical device. Ground truth for value assignment is established through laboratory methods, not expert adjudication.
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 device is a linearity set for an analytical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the expected values of Beta-Hydroxybutyric Acid in the linearity set samples is established through analytical testing/value assignment using quantitative assays on an indicated analyzer (e.g., "P-Modular Instrument, Roche Reagent" is mentioned for the values). This involves precise laboratory measurements.
8. The sample size for the training set
- Not applicable as this is not an algorithm/AI model that requires training data. The "training" for this product would be the manufacturing and quality control processes to ensure consistency.
9. How the ground truth for the training set was established
- Not applicable as this is not an algorithm/AI model. The "ground truth" for the manufactured product's components and values would be established through standard analytical chemistry and manufacturing quality control procedures.
Summary of Limitations Based on Document Content:
The provided 510(k) summary focuses on the analytical performance and stability of a quality control material. It does not contain information about clinical studies, diagnostic accuracy, human reader performance, AI algorithms, or "ground truth" established by clinical experts, which are typical expectations for the detailed questions provided. The data presented is intended to demonstrate the material's suitability for its stated purpose in verifying the performance of Beta-Hydroxybutyric Acid assays.
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Image /page/0/Picture/1 description: The image shows a logo for a company called "Aalto Scientific, Ltd." The logo consists of a triangular shape made up of many small dots, resembling a mountain or a pyramid. Below the triangular shape, the company name is written in a stylized font.
MAR 1 9 2013 510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
510(k) Summarv
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
B. Contact Person
Dessi Lyakov Regulatory Affairs Manager Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
February 15, 2013
D. Device Identification
| Product Trade Name: | Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Se |
|---|---|
| Common Name: | Beta-Hydroxybutyric Acid Linearity |
| Classification Name: | Assay QC Material |
| Device Classification: | Class I, reserved |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJX |
| Device to Which Substantial Equivalence is Claimed | |
| Product Trade Name: | Audit® MicroCVTM hs-CRP Linearity Set |
| Aalto Scientific, Ltd., Carlsbad, CA | |
| K101427 |
E. Description of the Device
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. 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.
F. Statement of Intended Use
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta-Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for
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510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta-Hydroxybutvric Acid,
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 Beta-Hydroxybutyric Acid. 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™ Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".
G. Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Audit® MicroCV™ Beta-Hydroxybutyric Acid 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 opened, the Beta-Hydroxybutyric Acid will be stable for 40 days when stored tightly capped at 2 - 8º C.
Shelf Life: Two years, when stored unopened at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product.
H. Expected Values
Value assignment of Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set have been performed to determine the expected values of Beta-Hydroxybutyric Acid analyte. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
| Beta-Hydroxybutyric Acid, mmol/L, P-Modular Instrument, Roche Reagent | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 0.0 | 0.0 | 1.2 | 1.0-1.4 | 2.3 | 2.0-2.6 | 3.4 | 2.9-3.9 | 4.4 | 3.8-5.1 |
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510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
| Characteristics | Audit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set(New) | Audit™ MicroCV™ hs-CRPLinearity Set(K101427) |
|---|---|---|
| Intended Use | The Audit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set is an assayed quality control materialconsisting of five levels of human based serum.Each level contains Beta-Hydroxybutyric Acid.These five levels demonstrate a linear relationshipto each other for Beta-Hydroxybutyric Acid. It isintended to simulate human patient serumsamples for purpose of determining linearity,calibration verification and verification ofreportable range for Beta-Hydroxybutyric Acid.The product is intended for use with quantitativeassays on the indicated analyzer provided in thelabeling and may be used as quality controlmaterial for Beta-Hydroxybutyric Acid. When usedfor quality control purposes, it is recommendedthat each laboratory establish its own means andacceptable ranges and use the values providedonly as guides. The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set should not beused for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™Beta-Hydroxybutyric Acid Linearity Set is "For InVitro Diagnostic Use Only". | The Audit™ MicroCV™ hs-CRP Linearity Setis assayed quality control material consistingof five levels human based serum. Eachlevel contains High Sensitivity C-ReactiveProtein (hs -CRP) analyte. The five levelsdemonstrate a linear relationship to eachother for High Sensitivity C-Reactive Protein(hs -CRP) analyte. It is intended to simulatehuman patient serum samples for purpose ofmonitoring and detecting systematicanalytical deviations of laboratory testingprocedures for High Sensitivity C-ReactiveProtein (hs -CRP). This product may be usedas quality control material for High SensitivityC-Reactive Protein (hs -CRP) analyte. Whenused for quality control purposes, it isrecommended that each laboratory establishits own means and acceptable ranges anduse the values provided only as guides. Theproduct is intended for use with quantitativeassays on the indicated analyzer provided inthe labeling, The Audit™ MicroCV™ hs-CRPLinearity Set is "For In Vitro Diagnostic UseOnly". |
| Number ofAnalytes per vial | 1 | 1 |
| Number oflevels per set | 5 | 5 |
| Contents | 5 x 1 mL | 5 x 1 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Beta-Hydroxybutyric Acid | High Sensitivity C-Reactive Protein |
| Form | Liquid | Liquid |
| Storage | 2 to 8 ° CUntil expiration date | 2 to 8 ° CUntil expiration date |
| Open VialStability | 40 days at 2 to 8 ° C | 20 days at 2 to 8 ° C |
I. Technical Characteristics Compared to Predicate Device
J. 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized representation of a human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the logo in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2013
Aalto Scientific, Ltd c/o Dessi Lyakov 1959 Kellogg Ave. Carlsbad, CA 92008
Re: K130157
Trade/Device Name: Audit ® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJX Dated: January 14, 2013 Received: February 06, 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/Industry/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: K130157
Device Name: Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
Indications for Use:
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid.
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 Beta-Hydroxybutyric Acid. 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™ Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung WOChan-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K130157
§ 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.