(286 days)
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No
The description focuses on the use of the device as a quality control material for linearity verification and does not mention any AI/ML components or functions.
No.
This device is an in vitro diagnostic quality control material used to verify the proper performance of quantitative assays for Homocysteine, not to treat a medical condition.
No
The device is a quality control material intended for verifying the linearity, calibration, and reportable range of Homocysteine assays, not for diagnosing patient conditions directly.
No
The device is a physical, liquid quality control material intended for in vitro diagnostic use, not a software application.
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™ Homocysteine Linearity Set is 'For In Vitro Diagnostic Use Only'."
- Intended Use: The intended use is to simulate human patient serum samples for the purpose of determining linearity, calibration verification, and verification of reportable range for Homocysteine on quantitative assays. This is a diagnostic purpose performed in vitro (outside the body).
- Device Description: The device is described as a "human based, liquid, five level set of QC material" used to "confirm the proper calibration, linear operating range, and reportable range of Homocysteine." This further supports its use in the diagnostic process.
Therefore, based on the provided text, the Audit™ MicroCV™ Homocysteine Linearity Set is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Audit™ MicroCV™ Homocysteine Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Homocysteine. It is used to confirm the proper calibration, linear operating range, and reportable range of Homocysteine. 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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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 the open vial stability and shelf life for the Audit™ MicroCVTM Homocysteine 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. Homocysteine will be stable for 10 days when stored tightly capped at 2 - 8° C.
Shelf Life: Two 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 for Aalto Scientific, Ltd. The logo consists of a triangle made up of many smaller triangles. The text "Aalto Scientific, Ltd" is written below the triangle.
DEC 2 3 2010
510(k) Summary
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™ MicroCVTM Homocysteine Linearity Set Homocysteine Linearity Set Assay QC Material Class I 21 CFR 862.1660 75 JJX
E. Device to Which Substantial Equivalence is Claimed
Product Trade Name:
Liquichek Homocysteine Control Bio-Rad Laboratories, Irvine, California K984071
Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318
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Description of the Device
The Audit™ MicroCV™ Homocysteine Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Homocysteine. It is used to confirm the proper calibration, linear operating range, and reportable range of Homocysteine. 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.
Statement of Intended Use
The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine 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™ MicroCVTM Homocysteine 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. Homocysteine will be stable for 10 days when stored tightly capped at 2 - 8° C.
Shelf Life: Two 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
| Audit™ MicroCV™ | Bio-Rad Liquichek | Audit™ MicroCV™ General | |
|---|---|---|---|
| Characteristics | Homocysteine Linearity Set | Homocysteine Control (K984071) | Chemistry Linearity Set |
| (K042318) | |||
| Intended Use | The Audit™ MicroCV™ | ||
| Homocysteine Linearity Set is | |||
| assayed quality control | |||
| material consisting of five | |||
| levels human based serum. | |||
| Each level contains | |||
| Homocysteine analyte. The | |||
| five levels demonstrate a | |||
| linear relationship to each | |||
| other for Homocysteine | |||
| analyte. It is intended to | |||
| simulate human patient serum | |||
| samples for purpose of | |||
| determining linearity, | |||
| calibration verification and | |||
| verification of reportable | |||
| range for Homocysteine. The | |||
| product is intended for use | |||
| with quantitative assays on the | |||
| indicated analyzer provided in | |||
| the labeling. The Audit™ | |||
| MicroCV™ Homocysteine | |||
| Linearity Set should not be | |||
| used for calibration or | |||
| standardization of the | |||
| Homocysteine assay. The | |||
| Audit™ MicroCV™ | |||
| Homocysteine Linearity Set is | |||
| "For In Vitro Diagnostic Use | |||
| Only". | A liquid control for | ||
| monitoring | |||
| homocysteine test | |||
| procedures. This | |||
| product can be used | |||
| for methods such as | |||
| HPLC and automated | |||
| immunoassay. | Audit™ MicroCV™ General | ||
| Chemistry Linearity Set is assayed | |||
| quality control material consisting of | |||
| human based serum. It is intended to | |||
| simulate human patient serum samples | |||
| for the purpose of monitoring the | |||
| precision and to detect systematic | |||
| analytical deviations of laboratory | |||
| testing procedures. This product may | |||
| also be used as unassayed quality | |||
| control material for these same | |||
| analytes. | |||
| Number of | |||
| Analytes per vial | 1 | 1 | 31 |
| Number of levels | |||
| per set | 5 | 2 | 5 |
| Contents | |||
| Matrix | 5 x 1mL | ||
| Human Serum | 6 x 1mL | ||
| Human Serum | 5 x 5 mL | ||
| Human Serum | |||
| Type of Analytes | Homocysteine | Homocysteine | Total Protein, Albumin, Alkaline |
| Phosphatase, ALT, Amylase, AST, | |||
| Bilirubin (Total and Direct), BUN, | |||
| Calcium, Chloride, Cholesterol, CO2, | |||
| Creatine Kinase, Creatinine, Gamma- | |||
| GT, Glucose, HDL Cholesterol, Iron, | |||
| LDH, LDL Cholesterol, Lactate, | |||
| Lipase, Magnesium, Phosphorus, | |||
| Potassium, Sodium, Total Protein, | |||
| Form | Liquid | Liquid | Lyophilized |
| Storage | 2 to 8° C | ||
| for 24 months | -10 to -70° C | ||
| for 36 months | 2 to 8° C for 24 months | ||
| Open Bottle | |||
| Stability | 10 days at 2 to 8° C | 14 days at 2 to 8° C | 7 days at 2 to 8° C |
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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 Ms. Dessi Lyakov Manager, Regulatory Affairs 1959 Kellogg Avenue Carlsbad, CA 92008
DEC 2 3 2010
Re: K100715
Trade Name: Audit™ MicroCV™ Homocysteine Linearity Set Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: November 22, 2010 Received: November 23, 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 Parts 801 and 809), 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 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/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
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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DEC 2 3 2010
510(k) Number: K100715
Device Name: Audit™ MicroCV™ Homocysteine Linearity Set
Indications For Use:
The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine 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 Benson
Sign-Off
്ചാ of In Vitro Diagnostic Device -tion and Safety