(37 days)
Not Found
No
The device is a linearity set for quality control of Vitamin D assays, not a diagnostic or analytical device that would typically incorporate AI/ML. The description focuses on the material composition and intended use for linearity verification and quality control.
No
The device is described as an "assayed quality control material" intended for "determining linearity, calibration verification and verification of reportable range for Vitamin D" in laboratory settings. It is explicitly stated as "For In Vitro Diagnostic Use Only" and "should not be used for calibration or standardization of the Vitamin D assay," indicating it is for diagnostic quality control and not for treating or diagnosing patients directly.
No.
The device is a quality control material used to verify the linearity, calibration, and reportable range of Vitamin D assays, not to diagnose medical conditions in patients.
No
The device is a physical quality control material consisting of serum, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Audit® MicroCV™ Vitamin D 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 Vitamin D on quantitative assays. This is a classic function of an in vitro diagnostic control material used in a laboratory setting to assess the performance of a diagnostic test.
- Device Description: The description confirms it's an assayed quality control material used to confirm the proper calibration, linear operating range, and reportable range of Vitamin D. These are all activities related to ensuring the accuracy and reliability of an in vitro diagnostic test.
- Care Setting: The intended user is implied to be in a laboratory setting, which is where IVD tests are performed.
Therefore, based on the provided information, the Audit® MicroCV™ Vitamin D Linearity Set clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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".
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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.
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
Not Found
Intended User / Care Setting
Not Found
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
Not Found
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® 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.
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).
Not Found
§ 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.
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 Claimed | |
| Product 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
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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 |
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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 of | ||
| Analytes per vial | 1 | 1 |
| Number of | ||
| levels 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° C | |
| Until expiration date | 2 to 8° C | |
| Until expiration date | ||
| Open Vial | ||
| Stability | 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
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
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