(30 days)
Not Found
Not Found
No
The device description details a chemical reaction and spectrophotometric detection method. There is no mention of AI/ML algorithms, image processing, or data analysis techniques that would suggest the use of AI/ML. The performance studies focus on analytical validation of the chemical test.
No
The provided text describes an in vitro diagnostic test that aids in risk stratification but does not directly treat a medical condition.
Yes
The device is described as a "quantitative in vitro diagnostic test used on human serum" and its intended use is "as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin" and "as an aid to rule out Acute Coronary Syndrome (ACS)". These statements clearly indicate its purpose is to diagnose or aid in the diagnosis of a medical condition.
No
The device is an in vitro diagnostic test that involves chemical reactions and spectrophotometric detection on clinical chemistry analyzers, indicating it is a hardware-based device with associated reagents.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "quantitative in vitro diagnostic test used on human serum".
- Device Description: The description details how the test is performed on a biological sample (human serum) outside of the body ("in vitro") to detect a specific substance (Ischemia Modified Albumin).
- Purpose: The test is intended to provide information about a patient's health status (aid to short term risk stratification of patients presenting with chest pain suggestive of cardiac origin).
These are all key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ischemia Albumin Cobalt Binding Test (ACB®) is 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 combined with negative, low, or normal ECG has not been established. IMA results do not correlate with ST segment changes and in the event of a positive IMA, ECG, or troponin test result, could be misleading as either ruling in or ruling out ACS.
Product codes
NJV
Device Description
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.
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
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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)
The following verification/validation testing was done for the additional analyzer: Typical Calibration Curve, Linearity, Sensitivity, Precision, Test Method Comparison, On Board Component Stability, Specificity, and Interfering Substances.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Albumin Cobalt Binding Test (ACB® Test)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K 053196
DEC 1 6 2005
(As required by 21 C.F.R. §807.92)
| Submitted by: | James Delaney
Inverness Medical Innovations, Inc.
51 Sawyer Rd., Ste. 200
Waltham, MA 02453 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared on: | December 14, 2005 |
| Device name | The Ischemia Albumin Cobalt Binding Test (ACB® Test) |
| Common name
Classification 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 labeling
changes. |
| Intended Use | The Ischemia Albumin Cobalt Binding Test (ACB®) is 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. |
| Technological
Characteristics | 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. |
| Testing | The following verification/validation testing was done for the additional analyzer:
Typical Calibration Curve, Linearity, Sensitivity, Precision, Test Method
Comparison, On Board Component Stability, Specificity, and Interfering Substances. |
1
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.
2
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
3
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)
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