CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN by ACCESS BIO INCORPORATE

CareStart™ Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, CK-MB and myoglobin in human blood, serum qualitative detection of cardiac troponin I, CK-MB and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac 2-in-1 Troponin I/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, and myoglobin in human blood, serum or plasma. detooking of cardiae troponin I, and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac CKMB Test is intended for the qualitative detection of CK-MB in human blood, serum or plasma. Measurement of CK-MB aids in rapid diagnosis of numan blood, corant of on. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac Troponin I Test is intended for the qualitative detection of cardiac oarcotar troponiir in haman broomyocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for the CareStart Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test, CareStart Cardiac 2-in-1 Troponin I/Myoglobin Test, CareStart Cardiac Troponin I, and CareStart Cardiac CK-MB devices.

Per the provided document, the FDA has determined that the device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria and performance metrics.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria and a study proving the device meets them in the format typically seen for novel devices requiring extensive clinical validation. The approval is based on the device's similarity to existing devices already on the market.

However, I can extract the information that is present concerning the intended use and performance in a general sense:

A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria nor reported device performance metrics (e.g., sensitivity, specificity, accuracy, PPV, NPV) from a dedicated study. The FDA's substantial equivalence determination implies that the device performs comparably to the predicate devices, which would have established performance characteristics.
Sample size used for the test set and the data provenance:
This information is not provided in the document. The filing is a 510(k) and does not detail a specific performance study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.
Adjudication method for the test set:
This information is not provided in the document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. These are in-vitro diagnostic tests for qualitative detection of biomarkers, not AI-assisted imaging or diagnostic devices where human reader performance would be a factor in an MRMC study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. These are diagnostic test kits, not algorithms. Their performance is inherent to the kit itself.
The type of ground truth used:
This information is not explicitly stated in the document. For in-vitro diagnostic tests like these, ground truth for performance studies would typically be established by laboratory reference methods or clinical diagnosis supported by multiple lines of evidence for the target condition (acute myocardial infarction).
The sample size for the training set:
This information is not provided in the document. (Not typically relevant for 510(k) submissions of IVD kits that are based on chemical reactions rather than machine learning algorithms.)
How the ground truth for the training set was established:
This information is not provided in the document. (Not typically relevant for 510(k) submissions of IVD kits.)

Summary of what can be inferred from the document:

Device Intended Use: The devices are intended for the qualitative detection of cardiac biomarkers (Troponin I, CK-MB, Myoglobin) in human blood, serum, or plasma to aid in the rapid diagnosis of acute myocardial infarction.
Regulatory Class: Class II
Prescription Use: All listed devices are for prescription use.
Point-of-Care (POC) Setting: The performance characteristics have not been evaluated in a point-of-care (POC) setting, meaning their use is intended for laboratory or clinical settings where trained personnel can perform the test.
Basis for Approval: Substantial equivalence to legally marketed predicate devices, meaning the FDA believes these devices are as safe and effective as existing devices for their stated indications. This does not involve independent clinical trials detailed within this specific 510(k) submission.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 9 2005

Young Ho Choi Access Bio, Inc. 2033 Route 130, Unit H Monmouth Junction, NJ 08852

Re: K051925

Trade/Device Name: CareStart Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test CareStart Cardiac 2-in-1 Troponin I/Myoglobin Test CareStart Cardiac Troponin I CareStart Cardiac CK-MB

Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JHT, DDR Dated: October 24, 2005 Received: October 26, 2005

Dear Mr. Choi:

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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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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto
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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510(k) Number (if known): K051925

Device Name: CareStart™ Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test

Indications For Use:

Prescription Use _ × (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)

Lucy Phillips
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(k) K051925

Page 1 of

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510(k) Number (if known): K051925

Device Name: CareStart™ Cardiac 2-in-1 Troponin I/Myoglobin Test

Indications For 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)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Tracy Phillips
Division Sign-Off

ice of In Vitro Diagnostic Device valuation and Safety

K051925

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510(k) Number (if known): K051925

Device Name:_CareStart™ Cardiac CKMB Test

Indications For Use:

Prescription Use × (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)

Page 1 of

Lucy Phillips
Vision Sign-Off

fice of In Vitro Diagnostic Device valuation and Safety

K051925

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510(k) Number (if known): K051925

Device Name:_CareStart™ Cardiac Troponin 1 Test

Indications For 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)

Page 1 of

Tracy Phillips
Sign-Off

Office of In Vitro Diagnostic Device Valuation and Safety

K051925

Regulation Number and Section

§ 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.