MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI

• K Number: K991299
• Device Name: MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
• Manufacturer: PRINCETON BIOMEDITECH CORP.
• Date Cleared: 1999-05-28 ( 52 days)
• Product Code: JHT , DDR
• Regulation Number: 862.1215
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.

Device Description

Not Found

AI/ML Overview

This looks like a medical device approval letter. I will do my best to extract the information you requested, but please note that due to the specialized nature of the document, some of the requested information might not be present or explicitly stated.

Based on the provided text, here's an analysis of the acceptance criteria and study information for the "Cardiac STATus CK-MB/Myoglobin Rapid One-Step Test":

No explicit acceptance criteria or detailed study results are provided in this document. This document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It does not typically contain the detailed performance study results or specific acceptance criteria that would have been submitted by the manufacturer.

However, I can infer some aspects based on the nature of a 510(k) submission for an in vitro diagnostic device:

1. A table of acceptance criteria and the reported device performance:

   • No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) are explicitly stated in this document. Such information would be detailed in the manufacturer's 510(k) submission, not typically in the FDA clearance letter itself.
   • Inferred based on the indication for use: As an "in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin... as an aid in the diagnosis of myocardial infarction," the device would have been evaluated for its ability to accurately detect the presence or absence of CK-MB and myoglobin, implying performance metrics like sensitivity, specificity, and potentially concordance with a reference method.

2. Sample sized used for the test set and the data provenance:

   • Not specified in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified in this document. For a diagnostic test like this, the "ground truth" for myocardial infarction would likely be established by clinical diagnosis, potentially involving multiple clinical factors and other diagnostic tests, rather than solely by a panel of experts reviewing the device's output.

4. Adjudication method for the test set:

   • Not specified in this document.

5. 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:

   • Not applicable. This device is an in vitro diagnostic test kit (a rapid one-step test for biochemical markers), not an AI-assisted diagnostic tool that humans would use to interpret images or other data. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. As an in vitro diagnostic assay, its performance is evaluated as a standalone product. The "test" itself generates the result. While a healthcare professional interprets the result in the context of a patient's overall clinical picture, the assay's performance characteristics (e.g., how accurately it detects the markers) are determined independently of human interpretation of its internal workings. The product is described as a "Rapid One-Step Test," suggesting it provides a direct qualitative result (e.g., positive/negative line on a strip).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated in this document. For a device "as an aid in the diagnosis of myocardial infarction," the ground truth for the clinical studies would typically involve:
     • Clinical diagnosis of MI: Based on a combination of clinical symptoms, ECG changes, and serial cardiac marker measurements (often using a laboratory-based, well-established reference method).
     • Reference method comparison: The device's CK-MB and Myoglobin results would be compared against established laboratory methods for these markers.

8. The sample size for the training set:

   • Not specified in this document. (Training sets are relevant for developing the assay, but the 510(k) primarily focuses on clinical validation.)

9. How the ground truth for the training set was established:

   • Not specified in this document. Similar to the test set, it would likely involve clinical diagnosis and comparison to reference laboratory methods during the development phase.

In summary, this FDA 510(k) clearance letter provides high-level information about the regulatory approval of the "Cardiac STATus CK-MB/Myoglobin Rapid One-Step Test" but does not contain the detailed study specifics (acceptance criteria, sample sizes, expert qualifications, ground truth methods, or performance metrics) typically found in the clinical study report itself. These details would have been part of the original 510(k) submission.

Summary

{0}------------------------------------------------

Received: April 06, 1999

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble a person with outstretched arms, representing health and well-being. The logo is black and white.

Food and Drug Administration Jemo Kang, Ph.D. 2098 Gaither Road MAY 2 8 1999 President Rockville MD 20850 Princeton Biomeditech Corp. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 Re : K991299 Trade Name: CardiacStAus CK-MB/Myoglobin Rapid One-Step Test . Requlatory Class: II Product Code: JHT, DDR Dated: March 31, 1999

Dear Mr. Kang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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}------------------------------------------------

Princeton BioMeditech Corp Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test 510(k) Notification

K 991399

510(k) Number (if Known): Not Known at this time

Device Name : Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test

Indications for Use:

The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.

Dean Cos
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991299

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Professional Use X

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)

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.