Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

Device Description

The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

AI/ML Overview

The ACE® Primidone Reagent is intended for the quantitative determination of primidone in human serum using the ACE® clinical chemistry analyzer. The device's performance was assessed by comparing it to a predicate device, the DRI Primidone Enzyme Immunoassay, and through non-clinical test results including within-run and between-run precision, and correlation against a Hitachi 717 analyzer.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" as pass/fail thresholds for precision or correlation. Instead, it presents the performance of the proposed device alongside the predicate device's performance for comparison, implying that performance comparable to or better than the predicate is acceptable.

Parameter	Implied Acceptance Criterion (Compared to Predicate)	Proposed Device Performance	Predicate Device Performance
Assay Range	Comparable or wider range	0.3 µg/mL to 24 µg/mL	0.5 µg/mL to 24 µg/mL
Precision (Within Run)	Comparable or better (%CV)	< 3.5 %CV	< 7.9 %CV
Precision (Between Run)	Comparable or better (%CV)	< 7.0 %CV	< 5.6 %CV
Correlation (Slope)	Close to 1 (vs. Hitachi 717)	0.998	0.92 (vs. Commercial Primidone assay)
Correlation (Intercept)	Close to 0 (vs. Hitachi 717)	-0.33	1.61 (vs. Commercial Primidone assay)
Correlation (r)	Close to 1 (vs. Hitachi 717)	0.988	0.978 (vs. Commercial Primidone assay)

2. Sample Sizes Used for the Test Set and Data Provenance

Correlation Test Set: N=50 samples were used for the correlation study of the proposed device against the Hitachi 717.
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only mentions "Non-clinical test results submitted," suggesting internal laboratory testing.

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

Not applicable. This device is a diagnostic reagent for quantitative determination, and its performance is evaluated against established analytical methods and instruments, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable for a quantitative diagnostic reagent. Ground truth is established through reference methods (like the Hitachi 717 analyzer) rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a diagnostic reagent, not an AI-powered image analysis or interpretation device. Therefore, MRMC studies are not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented (Assay Range, Precision, Correlation) represents the standalone performance of the ACE® Primidone Reagent when used on the ACE® clinical chemistry analyzer, without human interpretation as a primary output. Human involvement is limited to specimen handling and operating the instrument.

7. The Type of Ground Truth Used

For Correlation: The "ground truth" for the proposed device's correlation study was established by comparing its results to those obtained from the Hitachi 717 analyzer. This represents an established, high-quality, quantitative reference method.
For Precision: Precision (within-run and between-run) is an intrinsic measure of the device's reproducibility, not compared against an external "ground truth" in the same way as correlation.
For Assay Range: The assay range is determined through analytical validation studies using known concentrations of primidone.

8. The Sample Size for the Training Set

Not applicable. This is a diagnostic reagent (enzyme immunoassay) and does not involve machine learning algorithms that require a "training set" in the conventional sense. Its performance relies on the biochemical interactions of its reagents.

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

Not applicable, as there is no training set for this type of device.

Summary

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NOT : 1997

510(k) PREMARKET NOTIFICATION ACE® Primidone Reagent

SUMMARY OF SAFETY AND EFFECTIVENESS

In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is provided as a 510(k) summary for disclosure to any other persons/companies without specific written authorization from Schiapparelli Biosystems, Inc.

Submitter

Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, NJ 07004 Phone: (973) 882-8630

Contact Person

Steven Dalessio Manager, Quality Assurance/Regulatory Affairs Phone: (973) 882-8630

Device Names

Proprietary Name:	ACE® Primidone Reagent
Common Name:	Enzyme immunoassay for primidone
Classification Name:	Primidone test
Predicate Device:	Diagnostic Reagents, Inc. (DRI) - Primidone Reagent [510(k) NumberK960526]

Device Description

Intended Use of the Device

ACE® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.

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510(k) PREMARKET NOTIFICATION ACE® Primidone Reagent

SUMMARY OF SAFETY AND EFFECTIVENESS

COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES

PARAMETER	PREDICATE DEVICE	PROPOSED DEVICE
Trade Name	DRI Primidone EnzymeImmunoassay	ACE® Primidone Reagent
Reference No.	K960526	TBD
Analyte	Primidone	Primidone
Intended Use	Quantitative determination ofprimidone	Quantitative determination ofprimidone
Methodology	Enzyme immunoassay	Enzyme immunoassay
ReagentsReagent 1Volume	Liquid; Antibody/Substrate210 µL	Liquid; Antibody/Substrate210 µL
Reagent 2Volume	Liquid; Enzyme conjugate70 µL	Liquid; Enzyme conjugate70 µL
SpecimenTypeVolume	Serum and plasma5 µL	Serum3 µL
Assay SystemReagent 1 + SampleReagent 2Temperature	Incubate 300 secRead 60 and 120 sec37 °C	Incubate 240 secRead 63 and 273 sec37 °C
Detection MethodTypeWavelength, nm	SpectrophotometricBichromatic: 340/505	SpectrophotometricBichromatic: 340/505

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510(k) PREMARKET NOTIFICATION ACE® Primidone Reagent

SUMMARY OF SAFETY AND EFFECTIVENESS

PERFORMANCE ASSESSMENT

Non-clinical test results submitted in the premarket notification include within-run and between-run
er in the submitted in the first in a dote summary Non-cinlical test resures submitted in the proving is a data summary.

PARAMETER	PREDICATE DEVICE	PROPOSED DEVICE
Performance SummaryAssay Range	0.5 µg/mL to 24 µg/mL	0.3 µg/mL to 24 µg/mL
PrecisionWithin Run	<7.9 %CV	<3.5 %CV
Between Run	<5.6 %CV	<7.0 %CV
Correlation vs	Commercial primidone assay	Hitachi 717
Slope	0.92	0.998
Intercept	1.61	-0.33
r	0.978	0.988
N	104	50

Based on these data, the Schiapparelli Biosystems ACE® Primidone Reagent is substantially Based on these data, the Schiappatic Reagents, Inc. Princidone Enzyme Immunossay). On
equivalent to the predicate device (Diagnostic Reagents, Inc. Princeded use Performance equivalent to the predicate device (Libertine Reagents) me. I mindent of the programs of the programmendetails
this basis, the reagent is determined to be safe and effective are included in the reagent product labeling.

ﺍﻟﺘﻲ ﺗﻌﻠﻴﻘﺎ

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three faces in profile overlapping each other. The faces are connected to a flowing, ribbon-like shape at the bottom.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV I 2 1997

Steven Dalessio .Manager, Quality Assurance/Regulatory Affairs Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, New Jersey 07004

K973582 Re: ACE® Primidone Reagent Regulatory Class: II Product Code: DJD Dated: September 19, 1997 Received: September 22, 1997

Dear Mr. Dalessio:

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 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 Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation 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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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 (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 onthe 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 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

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Page 1 of 1 ..

510(k) Number (if known):_

ACE® Primidone Reagent Device Name:__

Indications For Use:

ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of Clinical Laboratory Devices
	510(k) Number	6973582
Prescription Use	OR	Over-The-Counter Use_
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3680 Primidone test system.

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