(37 days)
The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D.
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 Vitamin D. 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™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum, with each level containing Vitamin D. It is used to confirm the proper calibration, linear operating range, and reportable range of Vitamin D. 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.
{
"1": {
"title": "Acceptance Criteria and Reported Device Performance for Audit® MicroCV™ Vitamin D Linearity Set",
"table": {
"headers": [
"Vitamin D (ng/mL)",
"Level A",
"Level B",
"Level C",
"Level D",
"Level E"
],
"rows": [
[
"Target value",
"20.18",
"46.57",
"77.68",
"107.32",
"135.72"
],
[
"Target Range",
"17.15-23.21",
"39.58-53.55",
"66.03-89.33",
"91.22-123.42",
"115.36-156.08"
]
]
},
"notes": "The provided document specifically details the 'Expected Values' for the Audit® MicroCV™ Vitamin D Linearity Set. These expected values and their target ranges serve as the reported device performance and implicitly, the acceptance criteria for the linearity of the Vitamin D measurements across the five levels (A-E) on the Advia Centaur instrument using Siemens Reagent. The product is intended to demonstrate a linear relationship between these levels."
},
"2": "The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions that stability studies and value assignments were performed and that 'All supporting data is retained on file at Aalto Scientific, Ltd.'",
"3": "The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.",
"4": "The document does not specify an adjudication method for the test set.",
"5": "A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a quality control material, not an AI-assisted diagnostic tool for human readers.",
"6": "A standalone performance study was not explicitly described as 'algorithm only without human-in-the-loop performance'. The context is a quality control material for an instrument, not a standalone algorithm in the typical AI sense.",
"7": "The type of 'ground truth' for the expected values appears to be established through 'Value assignment' performed by the manufacturer, implying internal testing and validation against established laboratory methods or reference materials. It's described as 'Expected Values' determined for the Audit® MicroCV™ Vitamin D Linearity Set, suggesting a form of expert consensus or manufacturer-defined reference values for the particular instrument/reagent combination.",
"8": "The document does not specify the sample size for the training set.",
"9": "The document does not detail how the ground truth for a training set (if applicable) was established. The focus is on establishing expected values and stability for the quality control material itself."
}
{0}------------------------------------------------
*130764
Image /page/0/Picture/1 description: The image shows the logo for Aalto Scientific, Ltd. The logo consists of a triangle made up of many small dots. Below the triangle, the text "Aalto Scientific, Ltd." is written in a serif font.
510(k) Notification Audit® MicroCV™ Vitamin D Linearity Set
APR 2 6 2013
510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kelloag Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 (760) 431-6824 Fax:
B. Contact Person
Dessi Lyakovi 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® MicroCV™ Vitamin D Linearity Set |
|---|---|
| Common Name: | Vitamin D. 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 ClaimedProduct Trade Name: | Audit® MicroCV™ hs-CRP Linearity Set |
| Aalto Scientific, Ltd., Carlsbad, CA | |
| K101427 |
E. Description of the Device
The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum, with each level containing Vitamin D. It is used to confirm the proper calibration, linear operating range, and reportable range of Vitamin D. 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
ﺪ .
The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration
Page 3 of 5
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Image /page/1/Picture/0 description: The image shows a logo with a triangular shape at the top, filled with a pattern of dots or small circles. Below the triangle, there is text that reads "Aalto Scientific, Ltd". The text is in a smaller font size compared to the overall logo, and it appears to be the name or branding associated with the logo.
510(k) Notification Audit® MicroCV™ Vitamin D Linearity Set ... . . . .
verification and verification of reportable range for Vitamin D.
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 Vitamin D. 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™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D 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™ Vitamin D 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 Vitamin D will be stable for 30 days when stored tightly capped at 2 - 8º 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.
H. Expected Values
Value assignment of Audit® MicroCV™ Vitamin D Linearity Set have been performed to determine the expected values of Vitamin D analyte. All supporting data is retained on file at Aalto Scientific; Ltd. Product claims are as follows:
| Vitamin D. ng/mL, Instrument: Advia Centaur, Siemens 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 |
| 20.18 | 17.15-23.21 | 46.57 | 39.58-53.55 | 77.68 | 66.03-89.33 | 107.32 | 91.22-123.42 | 135.72 | 115.36-156.08 |
Page 4 of 5
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510(k) Notification Audit® MicroCV™ Vitamin D Linearity Set---------------------------------------------------------------------------------------------------------------------------------------
I. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit® MicroCV™ Vitamin D Linearity Set (New) | Audit™ MicroCV™ hs-CRP Linearity Set (K101427) |
|---|---|---|
| Intended Use | The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D.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 Vitamin D. 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™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D Linearity Set is "For In Vitro Diagnostic Use Only". | The Audit™ MicroCV™ hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. 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 product is intended for use with quantitative assays on the indicated analyzer provided in the labeling, The Audit™ MicroCV™ hs-CRP Linearity Set is "For In Vitro Diagnostic Use Only". |
| Number ofAnalytes per vial | 1 | 1 |
| Number oflevels per set | 5 | 5 |
| Contents | 5 x 2 mL | 5 x 1 mL |
| Matrix | Human and Equine Based Serum | Human Based Serum |
| Type of Analytes | Vitamin D | High Sensitivity C-Reactive Protein |
| Form | Liquid | Liquid |
| Storage | 2 to 8° CUntil expiration date | 2 to 8° CUntil expiration date |
| Open VialStability | 30 days at 2 to 8° C | 20 days at 2 to 8° C |
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 Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2013
Aalto Scientific, Ltd. C/O Dessi Lyakov 1959 Kellogg Ave. CARLSBAD CA 92008
Re: K130764
Trade/Device Name: Audit® MicroCV™ Vitamin D_Linearity_Set_ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I Product Code: JJX Dated: March 19, 2013 Received: March 29, 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 conceming 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
{4}------------------------------------------------
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-addresshttp://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol 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
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K130764
Device Name: Audit® MicroCVTM Vitamin D Linearity Set
Indications For Use:
-The-Audit®-MicroCVTM-Vitamin-D-Linearity-Set-is-an-assayed-quality-controlmaterial consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D.
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 Vitamin D. 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™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin-D --assay. The Audit® MicroCV™ Vitamin D 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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung W.j@han -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) = K130764
Page 1 of 1
§ 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.