(118 days)
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No
The 510(k) summary describes an ELISA assay for cardiac troponin I, which is a standard laboratory test and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic (IVD) test for quantitative determination of cardiac troponin I, which is used for evaluation of acute myocardial infarction. It does not actively treat or restore health.
Yes
The device is intended for the quantitative determination of cardiac troponin I in human serum to evaluate acute myocardial infarction, which is a diagnostic purpose.
No
The 510(k) summary describes an ELISA kit, which is a laboratory assay involving physical reagents and equipment, not a software-only device.
Yes, based on the provided information, the BioCheck cTnI ELISA is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of cardiac troponin I in human serum." This involves testing a biological sample (human serum) outside of the body (in vitro) to diagnose or evaluate a medical condition (acute myocardial infarction).
This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioCheck cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).
Product codes (comma separated list FDA assigned to the subject device)
MMI
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
8 2002 JAN
BioCheck, Inc. c/o Ms. Robin J. Hellen, M.S. President 9418 Lasaine Avenue Northridge,, CA 91325
K013062 Re:
Trade/Device Name: BioCheck, Inc. Human Cardiac Troponin I Enzyme Immunoassay Test Kit Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: November 16, 2001 Received: November 19, 2001
Dear Ms. Hellen:
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 he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his leation. The FDA finding of substantial equivalence of your device to a legally marketed nonication. The I Dir in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 It you desire specific acrivers diagnostic devices), please contact the Office of Compliance at additionally 009110 ditionally, for questions on the promotion and advertising of your device, (201) 594-4565) Production of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on 700 100peal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
PART I -- 510(k) Information
| III. | STATEMENT FOR INDICATIONS FOR USE |
|---|---|
| ------ | ----------------------------------- |
| JAN 8 2002 | |
|---|---|
| 510(k) Number (if known): | K013062 |
| Device Name: | BioCheck, Inc. Human Cardiac Troponin I |
| Enzyme Immunoassay Test Kit | |
| Indications for Use: | The BioCheck cTnI ELISA is intended for the quantitative determination of |
| cardiac troponin I in human serum. Measurement of troponin I values are | |
| useful in the evaluation of acute myocardial infarction (AMI). |
Concurrence of the CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K013062 |
|---|---|
| --------------- | --------- |
| Prescription Use: | OR | Over the Counter Use: |
|---|---|---|
| ------------------- | ---- | ----------------------- |