(175 days)
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No
The device is a quality control material for laboratory testing and does not involve any computational analysis or algorithms.
No
This device is an in vitro diagnostic quality control material used to assess the performance of laboratory tests for Ammonia and Ethanol, not to treat or diagnose patients directly.
No
This device is a quality control material intended to simulate patient samples and detect analytical deviations in laboratory testing procedures for Ammonia and Ethanol. It is not used to diagnose a patient's condition.
No
The device is a physical, in vitro diagnostic (IVD) quality control material, not a software-only device. It is a protein-based serum used to verify the calibration and linearity of laboratory analyzers.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Audit MicroCV Ammonia/Ethanol Linearity Set is 'For In Vitro Diagnostic Use Only.'"
- Intended Use: The intended use is to "detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol." This is a diagnostic purpose, as it helps ensure the accuracy of tests used to diagnose or monitor patient conditions.
- Nature of the Material: It is "assayed quality control material" and "intended to simulate human patient serum samples." Quality control materials are a fundamental part of in vitro diagnostic testing to ensure the reliability of the results.
- Care Setting: The intended user is involved in "laboratory testing procedures," which is the typical setting for in vitro diagnostic testing.
All these factors strongly indicate that this device falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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."
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Open Vial Stability: Once a vial has been opened, all analytes will be stable 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows a logo with a triangular shape at the top, filled with a pattern of small dots. Below the triangle, the text "Auto Scientific, Ltd." is printed in a simple, sans-serif font. The text is left-aligned and appears to be the name of a company or organization.
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 Linearity
Set |
|------------------------|--------------------------------------------------|
| 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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Image /page/2/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo consists of a triangle made up of many small dots, with the company name written below it. The text is in a simple, sans-serif font and is left-aligned. The logo is black and white and appears to be of moderate resolution.
H. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit™ MicroCV™ Ammonia/Ethanol
Linearity Set
(K100718) | Microgenics Document
Ammonia/Ethanol CAL VER
(K944338) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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." | DOCUMENT Ammonia/Ethanol
CAL•VER® solutions are intended
for in vitro diagnostic use in the
quantitative determination of
linearity, calibration verification,
verification of the Analytical
Measurement Range (AMR), and
verification of reportable ranges of
manual, automated and semi-
automated analytical chemistry
systems. |
| Number of
Analytes per vial | 2 | 2 |
| Number of levels
per set | 5 | 5 |
| Contents | 5 x 2 mL | 10 x 3 mL |
| Matrix | Protein-based, liquid | Protein-based, liquid |
| Type of Analytes | Ammonia
Ethanol | Ammonia
Ethanol |
| Form | Liquid | Liquid |
| Storage | 2 to 8° C
Until expiration date | -20° C
Until expiration date |
| Open Bottle
Stability | 2 days at 2 to 8° C | 2 to 8° C
Until 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