CREATINE KINASE (CK-NAC) by JAS Diagnostics, Inc.

Creatine kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Description

This Reagent is intended for the in vitro quantitative determination of creatine kinase in human serum.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the JAS Creatine Kinase (CK-NAC) Liquid Reagent:

Important Note: The provided document is a 510(k) summary for a medical device (a laboratory reagent), not a typical AI/ML device submission. Therefore, many of the requested categories like "multi-reader multi-case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "standalone (i.e. algorithm only without human-in-the-loop performance)" are not applicable as this is not an AI-powered diagnostic device. The evaluation of this device focuses on its chemical performance and equivalence to existing reagents, not the performance of an algorithm.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Intended Use	Identical to predicate devices.	"The JAS Creatine Kinase (CK-NAC) Liquid Reagent's intended use is identical to predicate Devices."
Performance	"Acceptable result comparisons" with predicate devices.	"Correlation studies on human serum demonstrated acceptable result comparisons between these methods" and "it's performance acceptable on the automated chemistry analyzers tested."
Normal Ranges	Similar normal ranges to predicate devices.	"which all use similar normal ranges."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "correlation studies on human serum" but does not provide a specific number of samples or subjects.
- Data Provenance: "human serum." The country of origin is not specified, but given the submitter's address in Miami, Florida, USA, it is likely from the United States. The studies appear to be retrospective or prospective clinical validation studies comparing the new reagent's performance against predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a chemical reagent, "ground truth" is typically established by the reference method or comparison to established, legally marketed predicate devices, not by expert interpretation in the way it would be for an image-based AI diagnostic. The comparison is against established laboratory testing methods.
Adjudication method for the test set:
- Not Applicable. As this is a chemical reagent, there's no "adjudication" in the sense of resolving disagreements between human readers or experts. The comparison is quantitative data obtained from automated chemistry analyzers.
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:
- No. This is a chemical reagent, not an AI-powered diagnostic device, so an MRMC study is not relevant or applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a lab reagent; there is no "algorithm" in the sense of AI. Its performance is measured as a component of an in vitro diagnostic test system.
The type of ground truth used:
- Reference Method/Comparative Performance: The ground truth for evaluating this reagent's performance is established by comparing its results to those obtained using legally marketed predicate devices (Roche Diagnostics CK NAC Reagent and Pointe Scientific Creatine Kinase (CK) Reagent) on automated chemistry analyzers. The aim is to demonstrate "acceptable result comparisons" and "similar normal ranges."
The sample size for the training set:
- Not Applicable. This is a chemical reagent; there is no "training set" in the context of machine learning. The term "training set" is typically used for AI/ML models.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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K013912

JAS DIAGNOSTICS: 510(K) NOTIFICATION

JAN 1 8 2002

510(K) SUMMARY

Submitter	Name: Attn: David JohnstonJAS Diagnostics, Inc.7220 N.W. 58th StreetMiami, FL 33166Phone: 305 418-2320Fax: 305 418-2321Email: D.Johnston@JASDiagnostics.com
Device Name:	Trade Name: JAS Creatine Kinase (CK-NAC) Liquid ReagentCommon Name: Creatine Kinase (CK) ReagentClassification Name: 21 CFR 862.1215
Predicate Devices:	-Roche Diagnostics CK NAC Reagent for the Roche Cobas Miraanalyzers-Pointe Scientific Creatine Kinase (CK) Reagent (generic)
Device Description:	This Reagent is intended for the in vitro quantitative determinationof creatine kinase in human serum.
Summary of theSimilarities to the	Intended Use: All devices are intended for the detection ofcreatine kinase (CK) in human serum on automated chemistryanalyzers.
Predicate Devices:	Results Interpretation: Correlation studies on human serumdemonstrated acceptable result comparisons between thesemethods, which all use similar normal ranges.
Discussion andConclusion:	The JAS Creatine Kinase (CK-NAC) Liquid Reagent's intendeduse is identical to predicate Devices and it's performanceacceptable on the automated chemistry analyzers tested. The JASCK-NAC Liquid Reagent is therefore substantially equivalent toFDA registered Creatine Kinase (CK) Reagents currently in themarket.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined figures that could be interpreted as snakes or stylized human profiles.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 8 2002

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

K013912 Re: K015912
Trade/Device Name: Creatine Kinase (CK) Reagent Regulation Number: 21 CFR 862.1215 Regulation Name: 21 Cr R 802.1223
Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System Regulatory Class: Class II Product Code: CGS Dated: October 22, 2001 Received: November 27, 2001

Dear Mr. Johnston:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 310(x) premained is substantially equivalent (for the indications ferenced above and nave determined in asketed predicate devices marketed in interstate for use stated in the enclosure to regars manent date of the Medical Device Ameral Food. Drug commerce prior to May 26, 1776, the enaounce with the provisions of the Federal Food, Drug, devices that have been icclassified in accession was a proval approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classinod (500 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of Pource in concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that i Driversity over device complies with other requirements of the Act that I DT has made a availations administered by other Federal agencies. You must of any I coural statutes and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 6077, laooning (21 CFR Part 820); and if applicable, the electronic forth in the quality bybelins (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 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

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Page __ 1_ of __ 1____________________________________________________________________________________________________________________________________________________________

K013912

510(k) Number (if known): ____ N/A Device Name: __ Creatine Kinase (CK) REAGENT Indications for Use:

Intended for the In Vitro, quantitative determination of creatine kinase (CK) in human serum on automated chemistry analyzers.

Creatine kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Jan Cooper

(Division.
Division cal Laboratory Devices
510(k) N. K01392

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

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.