N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM by BAYER CORP.

This in vitro method is intended to quantitatively measure n-acetylprocainamide, the pharmacologically active meabolite for procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® N-Acetylprocainamide Assay on a Bayer Immuno-1 system. Measurements of n-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of n-acetylprocainanide to ensure appropriate therapy.

Device Description

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Acceptance Criteria and Device Performance for N-Acetylprocainamide Assay

The provided document describes the N-Acetylprocainamide (NAPA) assay for the Bayer Immuno 1® System, seeking substantial equivalence to a predicate device (Syva EMIT® N-Acetylprocainamide Assay). The acceptance criteria are implicitly defined by the performance characteristics of the predicate device, against which the new device's performance is compared.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Predicate Device: Syva EMIT® NAPA Assay)	Reported Device Performance (Immuno 1 NAPA Assay)
Minimum Detectable Concentration	0.25 µg/mL	0.11 µg/mL
Precision (Total/Between-Run)	3.9% @ 1.7 µg/mL4.5% @ 4.5 µg/mL4.5% @ 10.8 µg/mL	5.5% @ 1.7 µg/mL4.3% @ 4.2 µg/mL6.5% @ 8.7 µg/mL
Correlation (vs. Predicate)	Implied strong correlation (r close to 1) and agreement (slope near 1, intercept near 0) with predicate.	y = 0.99x - 0.03r = 0.99Syx = 0.29 µg/mLn = 99

Interpretation:

Minimum Detectable Concentration: The Immuno 1 NAPA Assay demonstrated a lower minimum detectable concentration (0.11 µg/mL) compared to the predicate (0.25 µg/mL), indicating potentially better sensitivity.
Precision: The precision of the Immuno 1 NAPA Assay is comparable to the predicate, with some points slightly higher (e.g., 5.5% vs 3.9% at 1.7 µg/mL, and 6.5% vs 4.5% at 8.7/10.8 µg/mL) and some slightly lower (4.3% vs 4.5% at 4.2/4.5 µg/mL). Given the slight differences, the overall precision is considered acceptable for substantial equivalence.
Correlation: The Immuno 1 NAPA Assay shows excellent correlation with the predicate device, with an 'r' value of 0.99, a slope (0.99) very close to 1, and an intercept (-0.03) very close to 0. This indicates strong agreement between the two methods over the tested range.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: n = 99 for the correlation study.
Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it compares an existing predicate device with the new device using presumably collected samples, but this is not definitively stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This study is a method comparison for an in vitro diagnostic assay, not a study involving human interpretation of data by experts. The "ground truth" for the test set is established by the measurements obtained from the predicate device.

4. Adjudication Method for the Test Set

None. As this is a method comparison study, there is no human adjudication process involved. The performance of the new device is directly compared to the measurements from the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC study was not done. This describes an in vitro diagnostic assay, where the performance is based on quantitative measurements, not human reader interpretation. Therefore, the concept of human reader improvement with or without AI assistance is not applicable.

6. Standalone Performance Study

Yes, a standalone study was done in the sense that the new device's performance characteristics (Minimum Detectable Concentration, Precision, and Correlation) were evaluated independently. While its correlation was measured against a predicate device, its fundamental performance metrics were assessed for the algorithm/device itself.

7. Type of Ground Truth Used

The "ground truth" for the test set was the measurements provided by the predicate device (Syva EMIT® N-Acetylprocainamide Assay). The study aimed to demonstrate that the new device's measurements are substantially equivalent to those of the predicate.

8. Sample Size for the Training Set

Not specified. The document does not provide details about a training set. This type of in vitro diagnostic device typically undergoes method validation rather than machine learning model training specific to a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not specified. As there is no mention of a traditional "training set" for a machine learning model, the method for establishing ground truth for such a set is not detailed. The performance validation relies on comparing the new assay's output to an established method (the predicate device) on test samples.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

N-Acetylprocainamide Assay for Bayer Immuno 1° System

Listed below is a comparison of the performance between the Immuno 1 N-Acetylprocainamide (NAPA) assay and a Elsstor of a confed is a confed clearance of substantial equivalence (Syva EMIT® N-Acetylprocainamide Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno I N-Acetylorocainamide Method Sheet and the Syva EMIT® N-Acetylprocainamide Assay Insert Sheet.

INTENDED USED

METHOD	Immuno 1 NAPA Assay	Syva EMIT® NAPA Assay(predicate Device)
Part No.	T01-3990-51	4N024UL
Minimum Detectable Conc.	0.11 µg/mL	0.25 µg/mL
Precision	(Total)5.5% @ 1.7 µg/mL4.3% @ 4.2 µg/mL6.5% @ 8.7 µg/mL	(Between-Run)3.9% @ 1.7 µg/mL4.5% @ 4.5 µg/mL4.5% @ 10.8 µg/mL
Correlation	y = 0.99x - 0.03wherey = Immuno 1 N-Acetylprocainamide Assayx = Syva EMIT® N-Acetylprocainamide Assay*n = 99r = 0.99Syx = 0.29 µg/mL

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

Gabriel J. Murray, Jr.

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

ﺳﮯ

5/7/97

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 111 1997

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

K971713 Re :

N-Acetylprocainamide Assay for the Bayer Immuno 1™ System 发 Regulatory Class: II Product Code: LAN 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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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Paqe 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 (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 diaqnostic 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 Sitman

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):

N-Acetylprocainamide (NAPA) Device Name:_

Indications For Use:

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

T WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K171713
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.