(49 days)
Not Found
No
The document describes a set of serum-based samples used for verifying the accuracy of a specific assay on laboratory instruments. There is no mention of AI, ML, or any computational algorithms that would process data or make decisions.
No
Explanation: This device is for in vitro diagnostic use, specifically for verifying the accuracy of an assay on laboratory instruments. It is not used for treating or diagnosing a disease or condition in a patient.
No
The device is an Assay Verification Set (AVS) used to verify the accuracy of the ACB Test on specific Roche instruments. It is a calibrator/control product for an assay, not a diagnostic device itself, although it is for "In Vitro Diagnostic Use".
No
The device description explicitly states it consists of "twenty (20) single vial 0.5 mL aliquots of frozen serum based samples," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use". This is the primary indicator that the device is intended for use in testing samples taken from the human body (in vitro) to diagnose or monitor a medical condition.
N/A
Intended Use / Indications for Use
The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is intended for use in verifying the accuracy of the ACB Test on the Roche INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is recommended as part of assay installation.
For In Vitro Diagnostic Use.
Product codes
JJX
Device Description
The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.
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
The Assay Verification Set was evaluated for range setting values internally and at multiple clinical sites across the following laboratory instruments: the Roche Integra 700/800, Roche/Hitachi 917 and Roche Modular P. Results showed that AVS performs within specifications.
Key Metrics
Not Found
Predicate Device(s)
The Ischemia Albumin Cobalt Binding Test (ACB® Test) Assay Verification Set (AVS)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
| Submitted by: | James Delaney
Inverness Medical Innovations, Inc.
51 Sawyer Rd., Ste. 200
Waltham, MA 02453 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared on: | June 4, 2007 |
| Device name | The Ischemia Albumin Cobalt Binding Test (ACB® Test) Assay Verification
Set |
| Classification
name | Quality Control Material (assayed and unassayed) |
| | The Assay Verification Set is classified as Class I, Clinical Chemistry Panel
(75), Pro Code JJX-Single (Specified) Analyte Controls (Assayed and
Unassayed). The device is codified at 21 C.F.R. § 862.1660. |
| Predicate Device | The Ischemia Albumin Cobalt Binding Test (ACB® Test) Assay Verification
Set (AVS) |
| Modifications | Expanded the models of clinical analyzers validated for ACB assay installation
by AVS using revised acceptance criteria. |
| Intended Use | The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is
intended for use in verifying the accuracy of the ACB Test on the Roche
INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is
recommended as part of assay installation. |
| | For In Vitro Diagnostic Use. |
| Technological
Characteristics | The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots
of frozen serum based samples with assigned IMA values over the
physiological range. |
| Testing | The Assay Verification Set was evaluated for range setting values internally
and at multiple clinical sites across the following laboratory instruments: the
Roche Integra 700/800, Roche/Hitachi 917 and Roche Modular P. Results
showed that AVS performs within specifications. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 3 0 2007
Inverness Medical Innovations, Inc. c/o Mr. James Delaney Director Regulatory Affairs Cardiac Diagnostics 51 Sawyer Road. Ste. 200 Waltham, MA 02453
K071587 Re:
Trade/Device Name: The Inverness Medical Innovations, Inc. Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) Regulation Number: 21 CFR8862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJX Dated: July 13, 2007 Received: July 16, 2007
Dear Mr. Delaney:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
4071587
Device Name: The Inverness Medical Innovations, Inc. Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS)
Indications for Use: The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is intended for use in verifying the accuracy of the ACB Test on the Roche INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is recommended as part of assay installation.
For In Vitro Diagnostic Use
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 Bensen
Page 1 of
on Sign-O
Office of In Vitro Diagnostic Device Evaluation and Safety
071582