(122 days)
The Audit™ MicroCV™ Cardiac Markers Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains CKMB. Myoglobin, and Troponin I (Tnl) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When Audit™ MicroCVTM Cardiac Markers Linearity Set is 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 the analyzers indicated in the labeling. The Audit™ Cardiac Markers Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit™ MicroCV™ Cardiac Markers Linearity Set is a 5 level quality control solution set containing CKMB, Myoglobin, and Tnl analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of CKMB, Myoglobin, and TnI analytes. 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 text details a 510(k) premarket notification for the Audit™ MicroCV™ Cardiac Markers Linearity Set. This is a quality control material, not a medical device in the typical sense that uses AI, therefore most of the requested information regarding acceptance criteria for device performance, clinical studies, sample sizes, expert involvement, and ground truth establishment is not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing technical characteristics and stability, rather than establishing specific performance metrics for diagnostic accuracy.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Audit™ MicroCV™ Cardiac Markers Linearity Set) |
|---|---|---|
| Intended Use | To confirm proper calibration, linear operating range, and reportable range for various general chemistry analytes, and for quality control, proficiency testing, and CLIA-directed calibration verification for these analytes. | To confirm the proper calibration, linear operating range, and reportable range of CKMB, Myoglobin, and TnI analytes. For quality control purposes when a linear relationship between five levels for CKMB, Myoglobin, and TnI analytes is demonstrated. |
| Number of Levels per Set | 5 | 5 |
| Contents | 5 x 5mL | 5 x 1mL |
| Matrix | Human Serum | Human Serum |
| Type of Analytes | Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO₂, Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, Lactate, LDH, LDL Cholesterol, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides, and Uric Acid. | CKMB, Myoglobin, and Troponin I (TnI) |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8° C for 48 months | 2 to 8° C for 18 months |
| Open Bottle Stability | 7 days at 2 to 8° C | 5 days at 2 to 8° C |
Key takeaway on Acceptance Criteria: The acceptance criteria for this device are primarily demonstrated through substantial equivalence to the predicate device, K042318 (Audit™ MicroCV™ General Chemistry Linearity Set), in terms of intended use, number of levels, matrix, form, and the principle of linearity. The reported performance aligns with these characteristics, with explicit differences noted in analytes, stability durations, and contents volume. The submission does not define specific numerical performance thresholds (e.g., accuracy, precision) for the analytes within the linearity set itself, as its purpose is to verify the linearity of separate diagnostic analyzers.
Regarding the Study That Proves the Device Meets Acceptance Criteria:
The provided document describes the basis for FDA clearance (510(k)) which relies on demonstrating substantial equivalence. The "study" in this context refers to the data generated to support the claims of stability and the comparison to the predicate.
- Stability Studies: The document explicitly mentions that "Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ Cardiac Markers Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
- Open Vial Stability: 5 days when stored tightly capped at 2-8 C.
- Shelf Life: 18 months at 2 - 8º C.
- Note: Real time studies are ongoing to support the shelf life of this product."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary. For stability studies of linearity sets, this typically involves multiple lots, multiple vials per lot, and testing at various time points.
- Data Provenance: The studies were conducted by Aalto Scientific, Ltd. in Carlsbad, CA, USA. The data is retrospective in that it was collected prior to submission, but the "real-time studies are ongoing" comment indicates some prospective elements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a linearity set (a quality control material). Its "ground truth" is defined by its manufacturing process and the characterized concentrations of the analytes within each level. It is not a diagnostic device requiring expert interpretation of results for clinical ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As a quality control material, there is no clinical "test set" in the sense of patient data requiring adjudication. The characterization would follow standard analytical chemistry and quality control protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithmic device.
7. The Type of Ground Truth Used
- For the stability studies, the "ground truth" for the analyte concentrations at different time points would be established by analytical measurements using validated methods and reference materials (if applicable) at the time of manufacture and at various points during its shelf life. Linearity would be assessed by comparing the measured values across the five levels to an expected linear relationship.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No training set for an AI/ML algorithm is involved.
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510(k) Summary
JAN 1 0 2011
A. Submitter
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
December 23, 2010
D. Device Identification
Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Audit™ MicroCV™ Cardiac Markers 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:
Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318
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F. Description of the Device
The Audit™ MicroCV™ Cardiac Markers Linearity Set is a 5 level quality control solution set containing CKMB, Myoglobin, and Tnl analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of CKMB, Myoglobin, and TnI analytes. 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.
Statement of Intended Use
The Audit™ MicroCV™ Cardiac Markers Linearity Set is an assaved quality control material consisting of five levels human based serum. Each level contains CKMB. Myoglobin, and Troponin I (Tnl) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When Audit™ MicroCVTM Cardiac Markers Linearity Set is 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 the analyzers indicated in the labeling. The Audit™ Cardiac Markers Linearity Set is "For In Vitro Diagnostic Use Only".
I. Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ Cardiac Markers 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: 18 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
ﻟ ﻣﺎ
| Audit™ MicroCV™Cardiac Markers Linearity Set(New) | Audit™ MicroCV™General Chemistry Linearity Set(K042318) | |
|---|---|---|
| Characteristics | ||
| Intended Use | The Audit™ MicroCV™ CardiacMarkers Linearity Set is an assayedquality control material consisting offive levels human based serum. Eachlevel contains CKMB, Myoglobin, andTroponin I (TnI) analytes. The fivelevels demonstrate a linear relationshipto each other for CKMB, Myoglobin,and Tnl analytes. When Audit™MicroCV™ Cardiac Markers LinearitySet is used for quality control purposes,it is recommended that each laboratoryestablish its own means and acceptableranges and use the values provided onlyas guides. The product is intended foruse with quantitative assays on theanalyzers indicated in the labeling. TheAudit™ Cardiac Markers Linearity Setis "For In Vitro Diagnostic Use Only". | Audit® MicroCV™ General Chemistry Linearity Setconsists of five levels of human based serum. Eachlevel contains the following analytes: Albumin,Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin(Total and Direct), BUN, Calcium, Chloride,Cholesterol, CO2, Creatine Kinase, Creatinine,Gamma-GT, Glucose, HDL Cholesterol, Iron, Lactate,LDH, LDL Cholesterol, Lipase, Magnesium,Phosphorus, Potassium, Sodium, Total Protein,Triglycerides and Uric Acid. These five levelsdemonstrate a linear relationship to each other for theirrespective analytes, reagents and instruments¹.This product may also be used as unassayed qualitycontrol material for these analytes. When used forquality control purposes, it is recommended that eachlaboratory establish its own means and acceptableranges and use the values provided only as guides. Inaddition, it may be used for proficiency testing ininterlaboratory surveys and to perform CLIA directedcalibration verification² for these same analytes inaccordance with current CLIA-88 guidelines andregulations³. |
| Number of levels per set | 5 | 5 |
| Contents | 5 x 1mL | 5 x 5mL |
| Matrix | Human Serum | Human Serum |
| Type of Analytes | CKMB,Myoglobin,and Troponin I (TnI) | Albumin, Alkaline Phosphatase, ALT, Amylase, AST,Bilirubin (Total and Direct), BUN, Calcium, Chloride,Cholesterol, CO₂, Creatine Kinase, Creatinine, Gamma-GT,Glucose, HDL Cholesterol, Iron, Lactate, LDH, LDLCholesterol, Lipase, Magnesium, Phosphorus, Potassium,Sodium, Total Protein, Triglycerides and Uric Acid. |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8° C for 18 months | 2 to 8° C for 48 months |
| Open Bottle Stability | 5 days at 2 to 8° C | 7 days at 2 to 8° C |
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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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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Aalto Scientific Ltd. c/o Dessi Lyakov 1959 Kellogg Ave. Carlsbad, CA 92008 USA
Re: K102617
Trade Name: Audit™ MicroCV™ Cardiac Markers Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, Reserved Product Codes: JJY Dated: November 22, 2010 Received: November 23, 2010
JAN 1 0 2011
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, Ythe 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 either class II (Special Controls) or class III (PMA), 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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).
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Page 2 -
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 Diagnosuic 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-fre number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
:
Enclosure
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JAN 1 0 2011
Indications for Use
510(k) Number: New
Device Name: Audit™ MicroCV Cardiac Markers Linearity Set
Indications For Use:
The Audit™ MicroCV™ Cardiac Markers Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains CKMB. Myoglobin, and Troponin I (Tnl) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When Audit™ MicroCVTM Cardiac Markers Linearity Set is 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 the analyzers indicated in the labeling. The Audit™ Cardiac Markers 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K 102617
§ 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.