(134 days)
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No
The provided text describes qualitative immunoassay tests for cardiac markers and does not mention any AI or ML components.
No
The device aids in diagnosis, but does not provide therapy or treatment.
Yes
The device is intended for the "qualitative detection" of specific markers that "aids in rapid diagnosis of acute myocardial infarction," which is a diagnostic purpose.
No
The device description is not provided, but the intended use clearly describes a "Test" for the qualitative detection of biomarkers in human blood, serum, or plasma. This strongly suggests a physical diagnostic test kit, not a software-only device.
Yes, based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these tests are for the "qualitative detection of cardiac troponin I, CK-MB, and/or myoglobin in human blood, serum or plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The purpose is to "aid in rapid diagnosis of acute myocardial infarction." This is a diagnostic purpose, which is a key characteristic of IVDs.
The fact that they are intended for "Prescription Use" and have not been evaluated in a "point-of-care (POC) setting" further supports their classification as IVDs, likely intended for use in a laboratory or clinical setting under the supervision of healthcare professionals.
N/A
Intended Use / Indications for Use
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.
Product codes
MMI, JHT, DDR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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).
1
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
2
510(k) Number (if known): K051925
Device Name: CareStart™ Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test
Indications For Use:
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.
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
3
510(k) Number (if known): K051925
Device Name: CareStart™ Cardiac 2-in-1 Troponin I/Myoglobin Test
Indications For Use:
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.
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
4
510(k) Number (if known): K051925
Device Name:_CareStart™ Cardiac CKMB Test
Indications For Use:
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.
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
5
510(k) Number (if known): K051925
Device Name:_CareStart™ Cardiac Troponin 1 Test
Indications For Use:
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.
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