This in vitro diagnostic procedure is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno 17M system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of procainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.

Device Description

This in vitro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system.

AI/ML Overview

The provided document describes the Procainamide Assay for Bayer Immuno 1 System and its comparison to a predicate device, the Syva EMIT® Procainamide Assay.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (Predicate Device Performance)	Reported Device Performance (Immuno 1 Procainamide Assay)
Minimum Detectable Conc.	0.25 µg/mL	0.53 µg/mL
Precision	Between-Run:	Total:
	2.5% @ 2.4 µg/mL	3.1% @ 2.0 µg/mL
	3.0% @ 5.7 µg/mL	4.1% @ 7.6 µg/mL
	4.2% @ 9.7 µg/mL	7.0% @ 9.4 µg/mL
Correlation	(Not explicitly stated as a target, rather the Immuno 1 device's correlation to it is reported)	y = 0.95x + 0.24 (where y = Immuno 1, x = Syva EMIT®)
		n = 99
		r = 0.99
		Syx = 0.27 µg/mL

Note on Acceptance: The document states that the Immuno 1 Procainamide Assay was found substantially equivalent to the predicate device. This implies that the reported performance metrics of the Immuno 1 assay were deemed acceptable in comparison to the Syva EMIT® Procainamide Assay, even if they are not identical. For instance, the minimum detectable concentration is higher for the Immuno 1, and the precision categories (Total vs. Between-Run) are different, but the overall performance was considered sufficient for substantial equivalence.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: The correlation study involved n = 99 samples.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
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. For an in vitro diagnostic device like this, "ground truth" for the test set is typically established by comparative analysis against a validated reference method or another already cleared device (in this case, the predicate Syva EMIT® Procainamide Assay). The study is the comparison against a predicate device, so expert consensus on individual results isn't typically part of this specific type of submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided. The study relies on quantitative assay results, not subjective interpretations requiring adjudication.
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 information is not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The study described is inherently a standalone performance evaluation of the Immuno 1 Procainamide Assay system (which includes reagents, instrument, and method) against a predicate device. There is no human-in-the-loop component mentioned for the analytical performance of the assay itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this substantial equivalence submission is the performance of the legally marketed predicate device (Syva EMIT® Procainamide Assay). The study directly compares the new device's measurements to those obtained from the predicate device to demonstrate similar performance characteristics.
The sample size for the training set:
- This information is not provided. IVD assays typically don't have a "training set" in the machine learning sense. The assay is developed and optimized, then validated.
How the ground truth for the training set was established:
- This information is not provided and is generally not applicable for this type of IVD device. The methods for establishing the performance characteristics (e.g., linearity, precision, accuracy) during development and optimization would rely on calibrators and controls with known concentrations, potentially traceable to a primary reference standard, rather than a "ground truth" derived from a separate clinical set in the way AI models are trained.

Summary

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JUN 27 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

Procainamide Assay for Bayer Immuno 1 System

Listed below is a comparison of the performance between the Immuno 1 Procainamide assay and a similar device that was granted clearance of substantial equivalence (Syva EMIT® Procainamide Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Procainanide Method Sheet and the Syva EMIT® Procainamide Assay Insert Sheet.

INTENDED USED

This in viro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

METHOD	Immuno 1 Procainamide Assay	Syva EMIT® Procainamide Assay(predicate Device)
Part No.	T01-3988-51	4K024UL
Minimum Detectable Conc.	0.53 µg/mL	0.25 µg/mL
Precision	(Total)3.1% @ 2.0 µg/mL4.1% @ 7.6 µg/mL7.0% @ 9.4 µg/mL	(Between-Run)2.5% @ 2.4 µg/mL3.0% @ 5.7 µg/mL4.2% @ 9.7 µg/mL
Correlation	y = 0.95x + 0.24wherey = Immuno 1 Procainamide Assayx = Syva EMIT® Procainamide Assay*n = 99r = 0.99Syx = 0.27 µg/mL

*This assay was performed on COBAS FARA II® Instrument using parameters and protocol specified in Behring Application Sheet.

Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.

Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

5/7/97

Date

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 27 1997

Gabriel J. Muraca, Jr. Manager Requlatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

Re : K971716 Procainamide Assay for the Bayer Immuno 1™ System Requlatory Class: II Product Code: LAR Dated: May 7, 1997 Received: May 9, 1997

Dear Mr. Muraca:

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 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 Requlations.

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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 (770) 488-7655.

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 (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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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

510(k) Number (if known):

Procainamide (PROC) Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number	K971716

Prescription Use: (Per 21 CFR 801.109)	OR	Over-The-Counter Use
		(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3320 Digoxin test system.

(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.