(468 days)
Not Found
No
The device is a linearity set for quality control of a D-dimer assay, not a diagnostic device that processes data or images. The description focuses on the chemical composition and stability of the control material.
No.
Explanation: The device is a quality control material intended for in vitro diagnostic use to verify the calibration of a measuring range, not for treating a disease or condition.
No
This device is a linearity set used to verify the calibration of assay systems. It is a quality control material, not a device that directly diagnoses a patient's condition.
No
The device description clearly states it is a "human based, lyophilized, five level set of QC material," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "Audit TM MicroCV™ D-Dimer Linearity Set is 'For In Vitro Diagnostic Use Only.'"
- Intended Use: The device is intended to be used in vitro (outside the body) with a specific analyzer (Biomerieux miniVIDAS®) and assay (VIDAS® Ddimer assay) to verify the calibration of the measuring range for D-dimer. This is a diagnostic purpose, as it helps ensure the accuracy of a test used to diagnose or monitor a medical condition (related to D-dimer levels).
- Device Description: The description confirms it's a "human based, Iyophilized, five level set of QC material" used to "confirm the proper calibration, linear operating range, and reportable range" of D-dimer complex. This is a quality control material specifically designed for use in diagnostic testing.
Therefore, based on the provided information, the Audit™ MicroCV™ D-Dimer Linearity Set is an In Vitro Diagnostic device.
N/A
Intended Use / 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."
Product codes (comma separated list FDA assigned to the subject device)
GGN
Device Description
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 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.
0
Kl00716
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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
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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.
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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
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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
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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