(30 days)
The Ischemia Albumin Cobalt Binding Test (ACB®) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.
Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndrome (ACS) in low risk patients.
The safety and effectiveness of this device for use in patients with potential Acute Coronary Syndrome (ACS) with negative ECG; or positive ECG; or positive ECG combined with negative, low, or normal troponin levels; or positive troponin levels also has not been established. IMA results do not correlate with blood flow and in the event of a positive IMA, ECG, or troponin test result, could be misleading as either ruling in or ruling out ACS.
The Ischemia ACB® Test measures the cobalt binding capacity of albumin in a serum specimen. Cobalt is added to serum and allowed to react. Dithiothreitol (DTT), a colorimetric indicator, is added to the reacted specimen and the degree of color formation is detected spectrophotometrically on clinical chemistry analyzers.
In normal patients, cobalt binds at the N-terminus of albumin leaving little cobalt to react with DTT and form a colored product. In serum of patients with ischemia, cobalt does not bind to the metal binding sites leaving more free cobalt to react with DTT and form a darker color.
Here's a breakdown of the acceptance criteria and study information for the Ischemia Albumin Cobalt Binding Test (ACB® Test), based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, it lists the types of verification/validation testing performed. The "reported device performance" would be the results obtained from these tests, which are not detailed in this submission.
| Acceptance Criteria Category (Testing Performed) | Reported Device Performance |
|---|---|
| Typical Calibration Curve | Not specified |
| Linearity | Not specified |
| Sensitivity | Not specified |
| Precision | Not specified |
| Test Method Comparison | Not specified |
| On Board Component Stability | Not specified |
| Specificity | Not specified |
| Interfering Substances | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "patients presenting with chest pain suggestive of cardiac origin" for the intended use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not available in the provided document.
4. Adjudication Method for the Test Set
This information is not available in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic test for a biomarker, not an imaging or diagnostic device requiring human reader interpretation in the same way. The intended use is "in conjunction with ECG and cardiac troponin as an aid to the short-term risk stratification of patients."
6. Standalone (Algorithm Only) Performance Study
The Ischemia Albumin Cobalt Binding Test (ACB® Test) is an in-vitro diagnostic test that measures the cobalt binding capacity of albumin. While it's a quantitative test and can be run on clinical chemistry analyzers, it's not an "algorithm only" device in the sense of AI-driven image analysis or decision support. Its performance is inherent to the chemical reaction and measurement, not a separate algorithm. The "standalone performance" is implicitly covered by the "Typical Calibration Curve, Linearity, Sensitivity, Precision, Test Method Comparison, On Board Component Stability, Specificity, and Interfering Substances" testing.
7. Type of Ground Truth Used
For diagnostic tests like this, the "ground truth" would typically refer to the clinical diagnosis of Acute Coronary Syndrome (ACS) established by a combination of clinical assessment, ECG, cardiac troponin levels, and potentially other diagnostic procedures (e.g., angiography, outcomes data). The document itself does not specify how the ground truth was established for the study cohort, but mentions its use "in conjunction with ECG and cardiac troponin as an aid to the short-term risk stratification of patients presenting with chest pain suggestive of cardiac origin." The negative IMA result is used to "rule out Acute Coronary Syndrome (ACS) in low risk patients" with non-diagnostic ECG and normal troponin.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. For an in-vitro diagnostic device, this would typically refer to the samples used during development and optimization of the assay. This information is not provided.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a "training set" in the AI/ML context, this information is not applicable and not provided in the document. The development processes for chemical assays involve different methodologies for optimizing performance and establishing reference ranges.
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K 053196
DEC 1 6 2005
(As required by 21 C.F.R. §807.92)
| Submitted by: | James DelaneyInverness Medical Innovations, Inc.51 Sawyer Rd., Ste. 200Waltham, MA 02453 |
|---|---|
| Prepared on: | December 14, 2005 |
| Device name | The Ischemia Albumin Cobalt Binding Test (ACB® Test) |
| Common nameClassification name | Albumin Cobalt Binding Test, Class II, ProCode NJV, Regulation Number§ 862.1215. |
| Predicate Device | Albumin Cobalt Binding Test (ACB® Test) |
| Modifications | Expanded the models of clinical analysers for assay use with corresponding labelingchanges. |
| Intended Use | The Ischemia Albumin Cobalt Binding Test (ACB®) is quantitative in vitrodiagnostic test used on human serum that detects Ischemia Modified Albumin(IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMAis intended for use in conjunction with ECG and cardiac troponin as an aid to the shortterm risk stratification of patients presenting with chest pain suggestive of cardiacorigin.Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin,with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aidto rule out Acute Coronary Syndrome (ACS) in low risk patients. |
| TechnologicalCharacteristics | The Ischemia ACB® Test measures the cobalt binding capacity of albumin in a serumspecimen. Cobalt is added to serum and allowed to react. Dithiothreitol (DTT), acolorimetric indicator, is added to the reacted specimen and the degree of colorformation is detected spectrophotometrically on clinical chemistry analyzers.In normal patients, cobalt binds at the N-terminus of albumin leaving little cobalt toreact with DTT and form a colored product. In serum of patients with ischemia, cobaltdoes not bind to the metal binding sites leaving more free cobalt to react with DTTand form a darker color. |
| Testing | The following verification/validation testing was done for the additional analyzer:Typical Calibration Curve, Linearity, Sensitivity, Precision, Test MethodComparison, On Board Component Stability, Specificity, and Interfering Substances. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 16 2005
Mr. James M. Delaney Director Regulatory Affairs Inverness Medical Innovations, Inc. 51 Sawyer Rd., Ste. 200 Waltham, MA 02453
K053196 Re: K053190
Trade/Device Name: The Ischemia Albumin Cobalt Binding Test (ACB®) Regulation Number: 21 CFR 862.1215 Regulation Name: 21 CFR 062.1213
Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: NJV Dated: November 15, 2005 Received: November 16, 2005
Dear Mr. Delaney:
We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your bectoril 310(x) premaince is substantially equivalent (for the indications relerenced above and nave determined the article devices marketed in interstate for use stated in the Cherosule) to regard manetical Device Amendments, or to commerce prior to May 20, 1976, the enaoment with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosment Act (Fee) that do not require to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls providio of the tice, labeling, and prohibitions against misbranding and adulteration.
Please note that the limitations cited in the substantial equivalent letter for K023834, Albumin I least now the minitations one still applies to this device. Therefore the limitation must appear in the Warnings section of the device's labeling.
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 it may be subject to Subject to Such Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in 1 tere announcements concerning your device in the Federal Register.
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Page 2 – Mr. James M. Delaney
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subscunsive with other requirements of the Act
that FDA has made a determination that your device and well of arcepcies . You must that FDA nas made a delemination hial your arried by other Federal agencies. You must or any Federal statules and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not monuments of the many comply with an the Act s requirements, moraining, and good manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 CF R Farts 607 and 607), regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, per premarket nouncation. The PDA Intuing of bassanian organital organits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific information avour the appt wour device, allease contact the Office of In
or questions on the promotion and advertising of your a 1940 a 1994 and a post or questions on the promotion and advertising of your access-de-colors of (240) 240-0443 . Also, please note the Vitro Diagnostic Device Evaniation and Barey at (2005) at (210FR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the regulation entitled, "Misoranding by reiers not to presponsibilities under the Act from the You may other general mionmation on Jour Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000/050 = 6da.gov/cdrh/industry/support/index.html.
Sincerely yours,
Adato
Alberto Gutierrez, Ph.D.
Director -Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K053196 510(k) Number:
The Ischemia Albumin Cobalt Binding Test (ACB®) Device Name:
Indications For Use: The Ischemia Albumin Cobalt Binding Test (ACB®) is a indications i or Ose. The foonomia Albamin Serum that detects Ischemia qualititative in vitro diagnootio toot use a the cobalt binding capacity of albumin in Modified Albumin (fivin - ) by meadinny tho conjunction with ECG and cardiat troponin as
human serum. IMA is intended for use in conjunction with ECG and cardin human Scrum: "Ithir is microstratification of patients presenting with chest pain suggestive of cardiac origin.
Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, Trius, in patients with Chest pain of Squrrain, a negative IMA can be used as an aid to rule out Acute Coronary Syndrome (ACS) in low risk patients.
The safety and effectiveness of this device for use in patients with potential Acute The salely and choodronoos of this evels; or positive troponin levels Coronaly Oynaromo (100) with negative ECG; or positive ECG; or positive ECG combined combined with nogative, how also has not been established. IMA results do not with positive of normal troponial lovent of a positive IMA, ECG, or troponin test result, contrelate with alooded hell in the over could be misleading as either ruling in or ruling out ACS.
Prescription Use ___ × (Part 21 CFR 801 Subpart D) AND/OR ·
Over-The-Counter Use (21 CFR 807 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 | |
|---|---|
| Office | |
| Device Eval |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.