(468 days)
The Audit™ MicroCVTM D-Dimer Linearity Set is a quantitative, assayed quality control material consisting of five levels of D-dimer analyte. The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte. The Audit TM MicroCVTM D-Dimer Linearity Set is intended to use with the Biomerieux miniVIDAS® analyzer and VIDAS® Ddimer assay to verify the calibration of the measuring range. Audit TM MicroCV™ D-Dimer Linearity Set is "For In Vitro Diagnostic Use Only."
The Audit™ MicroCV™ D-Dimer Linearity Set is a human based, Iyophilized, five level set of QC material, with each level containing D-Dimer complex. It is used to confirm the proper calibration, linear operating range, and reportable range of D-Dimer complex, 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.
The provided text does NOT describe specific acceptance criteria and a study proving the device meets them in the typical sense of diagnostic accuracy or clinical performance.
Instead, the document is a 510(k) summary for a linearity set (Audit™ MicroCV™ D-Dimer Linearity Set), which is a quality control material intended to verify the calibration and linear operating range of an instrument (Biomerieux miniVIDAS® analyzer) for a D-Dimer assay. It is not a diagnostic device that directly measures a patient's condition.
Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device and submission.
Here's an analysis based on the provided content:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in terms of linearity. Instead, it describes its intended function: "The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte." The performance reported is primarily related to stability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Linearity: Demonstrate a linear relationship between the five D-Dimer levels. | "The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte." |
| Reconstituted Stability: Maintain stability for 2 days at 2-8°C. | "Once a vial has been reconstituted, all analytes will be stable for 2 days when stored tightly capped at 2 - 8° C." |
| Shelf Life: Maintain stability for 2 years when unopened at 2-8°C. | "Two Year, when stored unopened at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. For a linearity set, the "test set" would typically refer to the samples used to demonstrate linearity on the target instrument. The document mentions "All supporting data is retained on file at Aalto Scientific, Ltd." but does not elaborate on the sample sizes or provenance of these internal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a quality control material, not a diagnostic tool requiring expert interpretation of results. The "ground truth" for a linearity set would be the expected concentrations of D-Dimer in each level, established during manufacturing and characterized against a reference method.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI diagnostic tool and does not involve human readers in the context of comparative effectiveness for clinical diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical linearity set, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the linearity set itself, the "ground truth" would be the assigned D-Dimer concentration values for each of the five levels, which are pre-determined during manufacturing and characterization rather than being derived from clinical ground truth like pathology or expert consensus. These values are then used to verify the linearity of an instrument's measuring range.
8. The sample size for the training set
Not applicable. This device is not a machine learning or AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Kl00716
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, with the company name printed below it. The text is in a simple, sans-serif font and is left-aligned.
510(k) Notification Audit™ MicroCV™ D-Dimer Linearity Set JUN 2 3 2011
510(k) Summary
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 Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
June 9, 2011
D. Device Identification
| Product Trade Name: | Audit™ MicroCV™ D-Dimer Linearity Set |
|---|---|
| Common Name: | D-Dimer Linearity |
| Classification Name: | Plasma, Coagulation Control |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 864.5425 |
| Panel: | 81 Hematology |
| Product Code: | GGN |
E. Device to Which Substantial Equivalence is Claimed
Product Trade Name:
Triage® D-Dimer Calibration Verification Controls Biosite Incorporated, San Diego, CA 92121 K050799
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangle made up of many smaller triangles. The text "Aalto Scientific, Ltd" is written below the triangle.
510(k) Notification Audit™ MicroCV™ D-Dimer Linearity Set
F. Description of the Device
The Audit™ MicroCV™ D-Dimer Linearity Set is a human based, Iyophilized, five level set of QC material, with each level containing D-Dimer complex. It is used to confirm the proper calibration, linear operating range, and reportable range of D-Dimer complex, 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.
G. Statement of Intended Use
The Audit™ MicroCVTM D-Dimer Linearity Set is a quantitative, assayed quality control material consisting of five levels of D-dimer analyte. The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte. The Audit™ MicroCVTM D-Dimer Linearity Set is intended to use with the Biomerieux miniVIDAS® analyzer and VIDAS® Ddimer assay to verify the calibration of the measuring range. Audit TM MicroCVTM D-Dimer Linearity Set is "For In Vitro Diagnostic Use Only."
I. Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ D-Dimer Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Reconstituted Stability: Once a vial has been reconstituted, all analytes will be stable for 2 days when stored tightly capped at 2 - 8° C.
Shelf Life: Two Year, when stored unopened at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Aalto Scientific. Ltd. c/o Mr. Brandon Percz Regulatory Affairs Specialist 1959 Kellogg Ave. Carlsbad, CA 92008
JUN 2 3 2011
Re: K100716 Trade/Device Name: Audit™ MicroCVTM D-Dimer Linearity Set Regulation Number: 21 CFR 864.5425 Regulation Name: Plasma, Coagulation Control Regulatory Class: Class II Product Code: GGN Dated: June 9, 2011 Received: June 10, 2011
Dear Mr. Perez:
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 class II (Special Controls), 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). This letter
{3}------------------------------------------------
Page 2 - Ms. Brandon Perez
will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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,
m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangle made up of many small dots. The text "Aalto Scientific, Ltd." is written below the triangle in a simple font. The logo is simple and professional.
510(k) Notification Audit™ MicroCV™ D-Dimer Linearity Set
Indications for Use
510(k) Number: K100716
Device Name: Audit™ MicroCV™ D-Dimer Linearity Set
Indications For Use:
The Audit™ MicroCVTM D-Dimer Linearity Set is a quantitative, assayed quality control material consisting of five levels of D-dimer analyte. The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte. The Audit TM MicroCVTM D-Dimer Linearity Set is intended to use with the Biomerieux miniVIDAS® analyzer and VIDAS® Ddimer assay to verify the calibration of the measuring range. Audit TM MicroCV™ D-Dimer 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)
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K100716
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.