(175 days)
The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is "For In Vitro Diagnostic Use Only."
The Audit™ MicroCV™ Ammonia/Ethanol Linearity Set is a protein (bovine) based calibration verification material containing multiple levels used to confirm proper calibration, linear operating range, and reportable range of the measured analyte. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B - D are related by linear dilution of Level A and Level E.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Audit™ MicroCV™ Ammonia/Ethanol Linearity Set:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Not explicitly stated as acceptance criteria, but tested. | 2 days when stored stoppered at 2 - 8° C. |
| Shelf Life | Not explicitly stated as acceptance criteria, but tested. | 2 years, when stored unopened at 2 - 8° C. (Real-time studies ongoing) |
| Linearity | The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. | The device's intended use statement claims the five levels demonstrate a linear relationship. The study "retained on file at Aalto Scientific, Ltd." would presumably show this. |
| Equivalence to Predicate | "Substantially equivalent to the predicate device" (Microgenics Document Ammonia/Ethanol CAL•VER® K944338) | The conclusion states: "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." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly detail the sample size or provenance (country of origin, retrospective/prospective) of the data used for the performance studies. It simply states, "Stability studies have been performed to determine stability and shelf life for the Audit™ MicroCV™ Ammonia/Ethanol Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd." and refers to "stability data generated" for the substantial equivalence conclusion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that this is a linearity and stability test for an in vitro diagnostic quality control material, the concept of "experts establishing ground truth" in the common sense of clinical image review or diagnostic interpretation does not apply directly. The ground truth for this device would be established by:
- Analytical measurements: Precise laboratory equipment and reference methods would be used to determine the actual concentrations of Ammonia and Ethanol at each level.
- Time-point measurements: For stability studies, measurements would be taken at various time points to assess degradation or changes over time.
Therefore, no "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for this type of device. The expertise lies in the analytical chemists and laboratory personnel conducting the tests according to validated protocols.
4. Adjudication Method for the Test Set
Again, the concept of an adjudication method (like 2+1, 3+1 for clinical consensus) does not apply to the analytical performance testing described for this device. The assessment of linearity and stability would involve:
- Statistical analysis: Determining if the measured concentrations across the five levels indeed show a linear relationship using statistical methods (e.g., linear regression, acceptable deviation from linearity).
- Comparison to predefined limits: For stability, measured concentrations at different time points would be compared to initial concentrations or predefined stability specifications.
No human adjudication panel is necessary for these types of objective quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this device. This type of study is typically used for diagnostic devices that involve human interpretation (e.g., radiology AI tools to assess reader performance). The Audit™ MicroCV™ Ammonia/Ethanol Linearity Set is an in vitro diagnostic quality control material, not a device interpreted by human readers for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, the concept of a "standalone algorithm" is not applicable to this device. This device is a physical reagent set used to verify the performance of analytical chemistry systems (analyzers). It is not an algorithm, nor does it operate as a standalone diagnostic tool without human interaction (as it requires human setup and operation within a laboratory).
7. The Type of Ground Truth Used
The ground truth used for verifying the performance of this device would be:
- Analytical Reference Values: Established concentrations of Ammonia and Ethanol in the linearity set, ideally traceable to recognized reference materials or methods.
- Stability Specifications: Predetermined acceptable limits of variation from the initial reference values over time under specified storage conditions.
It relies on precise chemical measurements and validated laboratory procedures, not expert consensus, pathology, or direct outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm, so the concept of a "training set" does not apply. The manufacturer develops the product, then tests its analytical performance (linearity, stability).
9. How the Ground Truth for the Training Set Was Established
As stated above, there is no training set for this type of in vitro diagnostic quality control material.
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510(k) Summary
K100718 SEP . 3 2010
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 (760) 431-6824 Fax:
B. Contact Person
Dessi Lyakov Regulatory Affairs Manager dlyakov@aaltoscientific.com (760) 431-7922, Ext. 118
C. Date of Summary Preparation
February 26, 2010
D. Device Identification
| Product Trade Name: | Audit™ MicroCV™ Ammonia/Ethanol LinearitySet |
|---|---|
| Common Name: | Ammonia/Ethanol Linearity |
| Classification Name: | Multi-analyte controls (Assayed and Unassayed) |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJY |
E. Device to Which Substantial Equivalence is Claimed
Product Trade Name:
Document Ammonia/Ethanol CAL•VER® Microgenics Corporation, Fremont, Ca K944338
11: J
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F. Description of the Device
The Audit™ MicroCV™ Ammonia/Ethanol Linearity Set is a protein (bovine) based calibration verification material containing multiple levels used to confirm proper calibration, linear operating range, and reportable range of the measured analyte. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B - D are related by linear dilution of Level A and Level E.
G. Statement of Intended Use
The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is "For In Vitro Diagnostic Use Only".
I. Summary of Performance Data
Stability studies have been performed to determine stability and shelf life for the Audit™ MicroCV™ Ammonia/Ethanol Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Once a vial has been opened, all analytes will be stable Open Vial Stability: for 2 days when stored stoppered at 2 - 8° C.
Shelf Life: 2 years, when stored unopened at 2 - 8° 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
| Characteristics | Audit™ MicroCV™ Ammonia/EthanolLinearity Set(K100718) | Microgenics DocumentAmmonia/Ethanol CAL VER(K944338) |
|---|---|---|
| Intended Use | The Audit MicroCVAmmonia/Ethanol Linearity Set isassayed quality control materialconsisting of five levels protein(bovine) based serum. Each levelcontains Ammonia and Ethanolanalytes. The five levels demonstratea linear relationship to each other forAmmonia and Ethanol analytes. It isintended to simulate human patientserum samples and to detectsystematic analytical deviations oflaboratory testing procedures forAmmonia and Ethanol. This productmay be used as unassayed qualitycontrol material for Ammonia andEthanol analytes. The product isintended for use with quantitativeassays on the indicated analyzerprovided in the labeling. The AuditMicroCV Ammonia/EthanolLinearity Set is "For In VitroDiagnostic Use Only." | DOCUMENT Ammonia/EthanolCAL•VER® solutions are intendedfor in vitro diagnostic use in thequantitative determination oflinearity, calibration verification,verification of the AnalyticalMeasurement Range (AMR), andverification of reportable ranges ofmanual, automated and semi-automated analytical chemistrysystems. |
| Number ofAnalytes per vial | 2 | 2 |
| Number of levelsper set | 5 | 5 |
| Contents | 5 x 2 mL | 10 x 3 mL |
| Matrix | Protein-based, liquid | Protein-based, liquid |
| Type of Analytes | AmmoniaEthanol | AmmoniaEthanol |
| Form | Liquid | Liquid |
| Storage | 2 to 8° CUntil expiration date | -20° CUntil expiration date |
| Open BottleStability | 2 days at 2 to 8° C | 2 to 8° CUntil expiration date |
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Aalto Scientific, Ltd. c/o Dessi Lyakov 1959 Kellogg Avenue Carlsbad, CA 92008
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Re: K100718
Trade Name: Audit MicroCV Ammonia/Ethano} Linearity Set, Model K712M-5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, Reserved . Product Codes: JJY Dated: August 20, 2010 SEP 8 2010 Received: August 20, 2010
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, 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.
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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
signature
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
NewSEltr.
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Indications for Use
SEP . 3 2010
510(k) Number: K100718
Device Name: Audit™ MicroCV™ Ammonia/Ethanol Linearity Set
Indications For Use:
"The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is "For In Vitro Diagnostic Use Only."
Prescription Use (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)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K100718
§ 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.