The ACE® Carbamazepine Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to carbamazepine 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® Carbamazepine Reagent is an enzyme immunoassay intended for the quantitative determination of carbamazepine in human serum.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device K955100)	Reported Device Performance (ACE® Carbamazepine Reagent)
Assay Range	0.5 µg/mL to 20 µg/mL	0.3 µg/mL to 20 µg/mL
Precision
Within Run	<3.1 %CV	<4.7 %CV
Between Run	<8.2 %CV	<8.2 %CV
Correlation vs.	Commercial Carbamazepine assay	Hitachi 717
Slope	0.91	0.947
Intercept	-0.1	0.21
r (correlation)	0.970	0.986
N (sample size)	99	48

Note: The document implies the predicate device's performance serves as the de-facto acceptance criteria for substantial equivalence.

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

Sample Size for Correlation Study:
- For the comparison with the commercial carbamazepine assay (predicate device), the sample size was N=99.
- For the comparison with the Hitachi 717, the sample size was N=48.
Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "Non-clinical test results submitted..."

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

Not applicable. This device is an in vitro diagnostic (IVD) for quantifiable analytes (carbamazepine concentration). Ground truth is established by a reference method or validated analyzer, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device study. Ground truth is determined by quantitative measurements against a recognized method or instrument, not through human adjudication of qualitative findings.

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

No, an MRMC study was not done. This is not applicable for an IVD device measuring a chemical analyte. MRMC studies are typically used for medical imaging devices where human interpretation plays a significant role.

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

Yes, the performance assessment described is a standalone performance of the ACE® Carbamazepine Reagent. It evaluates the device's accuracy, precision, and correlation with other methods, without human intervention in the measurement process. The device itself is designed to provide a quantitative result.

7. The Type of Ground Truth Used

The ground truth was established by comparison to:

A "Commercial Carbamazepine assay" (for the predicate device comparison).
A "Hitachi 717" analyzer (for the proposed device's correlation study).

These are established laboratory methods/instruments used for measuring carbamazepine concentrations, serving as the reference standard or "ground truth" for quantitative accuracy.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. For an IVD reagent kit, training data often refers to internal development and validation data, which is typically not detailed in a 510(k) summary in this manner. The reported data pertains to the performance evaluation/test set.

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

Not applicable, as a distinct "training set" with established ground truth in the context of machine learning is not described or relevant for this type of chemical reagent 510(k) submission. The performance assessment describes the device's capabilities against existing, accepted quantitative methods.

Summary

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OCT 20 1997

510(k) PREMARKET NOTIFICATION ACE® Carbamazepine 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® Carbamazepine Reagent
Common Name:	Enzyme immunoassay for carbamazepine (Tegretol®)
Classification Name:	Carbamazepine test
Predicate Device:	Diagnostic Reagents, Inc. (DRI) - Carbamazepine Reagent [510(k)Number K955100]

Device Description

Intended Use of the Device

ACE® Carbamazepine Reagent is intended for use in the quantitative determination of carbamazepine in human serum.

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510(k) PREMARKET NOTIFICATION ACE® Carbamazepine Reagent

SUMMARY OF SAFETY AND EFFECTIVENESS

COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES

PARAMETER	PREDICATE DEVICE	PROPOSED DEVICE
Trade Name	DRI Carbamazepine EnzymeImmunoassay	ACE® Carbamazepine Reagent
Reference No.	K955100	TBD
Analyte	Carbamazepine	Carbamazepine
Intended Use	Quantitative determination ofcarbamazepine	Quantitative determination ofcarbamazepine
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	Serum5 µL
Assay SystemReagent 1 + SampleReagent 2Temperature	Incubate 300 secRead 60 and 120 sec37 °C	Incubate 240 secRead 63 and 203 sec37 °C
Detection MethodTypeWavelength, nm	SpectrophotometricBichromatic: 340/505	SpectrophotometricBichromatic: 340/505

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510(k) PREMARKET NOTIFICATION ACE® Carbamazepine Reagent

SUMMARY OF SAFETY AND EFFECTIVENESS

PERFORMANCE ASSESSMENT

Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation. Following is a data summary.

PARAMETER	PREDICATE DEVICE	PROPOSED DEVICE
Performance SummaryAssay RangePrecisionWithin RunBetween Run	0.5 µg/mL to 20 µg/mL<3.1 %CV<8.2 %CV	0.3 µg/mL to 20 µg/mL<4.7 %CV<8.2 %CV
Correlation vsSlopeInterceptrN	Commercial Carbamazepine assay0.91-0.10.97099	Hitachi 7170.9470.210.98648

Based on these data, the Schiapparelli Biosystems ACE® Carbamazepine Reagent is substantially equivalent to the predicate device (Diagnostic Reagents, Inc. Carbamazepine Enzyme Immunoassay). On this basis, the reagent is determined to be safe and effective for its intended use. Performance details are included in the reagent product labeling.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing individuals or families, in a flowing, abstract design.

OCT 20 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re : K973535 ACE® Carbamazepine Reagent Regulatory Class: II Product Code: KLT, DKB September 17, 1997 Dated: Received: September 18, 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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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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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 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 Litman

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 _ of _

510(k) Number (if known): K673535

ACE® Carbamazepine Reagent Device Name:_

Indications For Use:

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

Carbamazepine is an anticonvulsant drug, used in particular for the treatment of trigeminal neuralgia, all forms of partial epilepsy, generalized tonic-clonic seizures, and simple and complex partial seizures. The specific mechanism of carbamazepine is proposed as a depressant action on transmission through the nucleus ventralis anterior of the thalamus.

(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	K973535

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

Regulation Number and Section

§ 862.3645 Neuroleptic drugs radioreceptor assay test system.

(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.