Ischemia Albumin Cobalt Binding Test (Acb Test)
FDA 510(k) K053196 · Inverness Medical Innovations, Inc.
Submission
- Device name
- Ischemia Albumin Cobalt Binding Test (Acb Test)
- Applicant
- Inverness Medical Innovations, Inc.
Waltham, MA, US - Received
- November 16, 2005
- Decision date
- December 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NJV – Test, Albumin Cobalt Binding
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of…
Other 510(k)s with product code NJV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023824 | Albumin Cobalt Binding Test (Acb Test)NJV · Traditional | Ischemia Technologies, Inc. | 02/14/2003SESU |
More from Ischemia Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071265 | Smartcheck Inr SystemJPA · Traditional | 11/30/2007SE |
| K071587 | Ischemia Albumin Cobalt Binding Test (Acb Test) AssayJJX · Special | 07/30/2007SE |
| K060133 | Ischemia Albumin Cobalt Binding Test (Acb) Assay Verification SetJJX · Traditional | 02/16/2006SE |
| K011479 | One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood…CGA · Traditional | 11/30/2001SE |
| K011616 | Induo Blood Glucose MeterNBW · Special | 06/21/2001SE |
Questions and answers
When was Ischemia Albumin Cobalt Binding Test (Acb Test) cleared by the FDA?
Ischemia Albumin Cobalt Binding Test (Acb Test) (K053196) received a 510(k) decision of Substantially Equivalent on December 16, 2005, 30 days after the submission was received.
What is the product code of K053196?
The FDA product code is NJV – Test, Albumin Cobalt Binding, a Class II (moderate risk) device regulated under 21 CFR 862.1215.