IMMULITE® Amphetamine is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and designed for the qualitative measurement of Amphetamine in urine. It is intended strictly for in vitro diagnostic use in clinical laboratories, in the context of a program involving an established confirmatory test for amphetamine. A cutoff of 500 ng/mL is used by the IMMULITE Amphetamine assay to identify positive and negative results.

Device Description

IMMULITE® Amphetamine is a solid-phase chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text for the IMMULITE® Amphetamine device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in a quantitative manner (e.g., "sensitivity must be >X%"). Instead, the performance is reported as a comparison to two other methods, demonstrating substantial equivalence. The implied acceptance is that the device performs comparably to established methods for amphetamine detection in urine.

Performance Metric	IMMULITE Amphetamine vs. DPC's Double Antibody Amphetamine (Predicate Device)	IMMULITE Amphetamine vs. GC/MS (Confirmatory Method)
Relative Sensitivity	100% (Positive vs. Positive: 32/32)	Not explicitly reported as "relative sensitivity" but implied by 0 false negatives.
Relative Specificity	98% (Negative vs. Negative: 125/128)	Not explicitly reported as "relative specificity" but implied by 4 false positives.
Agreement	98% (Overall agreement: (32+125)/160)	Not explicitly reported.
False Positives	3/128 (2.3% when DAb Amphetamine was negative)	4/32 (12.5% when GC/MS was negative)
False Negatives	0/32 (0% when DAb Amphetamine was positive)	0/18 (0% when GC/MS was positive)

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

Test Set 1 (vs. DPC's Double Antibody Amphetamine): 160 urine samples.
Test Set 2 (vs. GC/MS): 50 urine samples.
Data Provenance: The samples were obtained from "volunteer donors, presumed not to be drug abusers, and from a reference lab." This suggests a mix of potentially healthy individuals and samples that might represent a broader clinical spectrum. The study appears to be retrospective as these samples were collected and then analyzed with both methods. The country of origin is not explicitly stated.

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

No direct mention of "experts" in the context of establishing ground truth. The ground truth for comparative studies was based on:

The results of a predicate device (DPC's Double Antibody Amphetamine assay).
The results of GC/MS (Gas Chromatography/Mass Spectrometry), which is typically considered a gold standard confirmatory method for drug testing but doesn't involve human 'experts' establishing a subjective ground truth.

4. Adjudication Method for the Test Set

Not applicable. The comparisons are against a predicate device and a confirmatory analytical method (GC/MS) rather than subjective expert interpretations requiring adjudication.

5. 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

Not applicable. This device is an in-vitro diagnostic (IVD) assay for chemical analysis, not an imaging or diagnostic device that involves human readers interpreting results with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this was a standalone performance study. The IMMULITE® Amphetamine assay is an automated, solid-phase chemiluminescent enzyme immunoassay. Its performance was evaluated purely on its analytical output compared to other analytical methods. The results generated by the device are quantitative (photon output) and then categorized as positive/negative based on a predefined cutoff of 500 ng/mL, making it an "algorithm only" type of performance without human interpretation as part of its primary function.

7. The Type of Ground Truth Used

For comparison against the predicate device: The ground truth was the result from the DPC's Double Antibody Amphetamine assay. This is a comparator method, serving as a de facto "ground truth" for demonstrating substantial equivalence.
For comparison against GC/MS: The ground truth was the result from GC/MS. This is a confirmatory analytical method, widely considered a "gold standard" for drug identification and quantification in toxicology.

8. The Sample Size for the Training Set

The document does not provide information about a "training set." This type of device (immunoassay) typically involves assay development and calibration rather than machine learning training in the conventional sense. The "Adjustor supplied with the kit" serves as a calibrator to define the 500 ng/mL cutoff for qualitative results.

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

Not applicable, as no conventional "training set" with ground truth in the AI/ML sense is mentioned or implied for this type of immunoassay. The cutoff (500 ng/mL) is an established regulatory threshold for amphetamine screening. The "Adjustor" in the kit is used to set the cutoff, and its value would be determined during the assay's development and manufacturing quality control to align with the 500 ng/mL threshold.

Summary

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K992632

510 (k) Summary Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

Name:	Diagnostic Products Corporation
Address:	5700 West 96th StreetLos Angeles, CA 90045
Telephone Number:	(310) 645-8200
Facsimile Number:	(310) 645-9999
Contact Person:	Edward M. Levine, Ph.D.Director of Clinical Affairs
Date of Preparation:	December 15, 1999
Device Name:	IMMULITE® Amphetamine
Trade:
Catalog Number:	LKAM1 (100 tests), LKAM5 (500 tests)
CFR:	An amphetamine test system is a device intended tomeasure amphetamine, a central nervous systemstimulating drug, in plasma and urine. Measurementsobtained by this device are used in the diagnosis andtreatment of amphetamine use or overdose and inmonitoring levels of amphetamine to ensure appropriatetherapy.
Common:	Reagent system for the determination of Amphetamine inurine.
Classification:	Class II device, 91-DKZ (21 CFR 862.3100)
Panel:	Toxicology
CLIA ComplexityCategory:	We believe the category to be moderate, based on previousclassification of analogous tests.
Manufacturer	Diagnostic Products Corporation (DPC)5700 West 96th StreetLos Angeles, CA 90045-5597

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EstablishmentRegistration #:	DPC's establishment Registration No. is 2017183
Substantially EquivalentPredicate Device:	DPC's Double Antibody Amphetamine (K871696)
Description of Device:	IMMULITE® Amphetamine is a solid-phasechemiluminescent enzyme immunoassay for use with theIMMULITE® Automated Analyzer.
Intended Use of theDevice:	IMMULITE® Amphetamine is a solid-phasechemiluminescent enzyme immunoassay for use with theIMMULITE Automated Analyzer and designed for thequalitative measurement of Amphetamine in urine. It isintended strictly for in vitro diagnostic use in clinicallaboratories, in the context of a program involving anestablished confirmatory test for Amphetamine. A cutoffof 500 ng/mL is used by the IMMULITE Amphetamineassay to identify positive and negative results.

Summary and Explanation of the test:

Amphetamine is a potent sympathomimetic amine capable of stimulating the central nervous system. There are two stereoisomers; d-amphetamine is three to four times more potent than I-amphetamine. The main results of an oral dose of amphetamine (10 to 30 mg) are increased alertness and wakefulness, with decreased sense of fatigue; an elevation of mood, concentration and self-confidence; and elation and euphoria. Amphetamine and similar drugs also suppress the appetite, and have been used in weightloss programs.

Amphetamines may be metabolized by p-hydroxylation, N-demethylation, deamination and conjugation. Nevertheless, substantial amounts are excreted unchanged in the urine. This process is influenced by urinary pH. Low amounts are excreted unchanged in alkaline urine, but as much as 80% of a dose can be excreted in acid urine.

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Technological Comparison to Predicate:

IMMULITE Amphetamine is a solid-phase, chemiluminescent immunoassay. The solid-phase, a polystyrene bead enclosed within a IMMULITE Test Unit, is coated with a monoclonal antibody specific for amphetamine.

The patient sample and alkaline phosphatase-conjugated amphetamine are simultaneously introduced into the Test Unit and incubated for approximately 30 minutes at 37 ℃ with intermittent agitation. During this time, amphetamine in the samples competes with enzyme-labeled amphetamine for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes.

The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of amphetamine in the sample. A qualitative result is then obtained by comparing the counts per second (cps) of the patient sample to those of a sample - the Adjustor supplied with the kit - representing the assay's 500 ng/mL cutoff.

DPC's Double Antibody Amphetamine procedure is a competitive radioimmunoassay in which 125I-labeled amphetamine competes with amphetamine in the sample for antibody sites. After incubation for a fixed time, separation of bound from free is achieved by the PEG-accelerated double-antibody method. Finally, the antibody-bound fraction is precipitated and counted. The counts per minute in the sample tube are then compared to the counts per minute of the Positive Amphetamine Reference cutoff.

Performance Equivalence:

Diagnostic Products Corporation asserts that the IMMULITE® Amphetamine produces substantially equivalent results to other commercially marketed amphetamine assays. such as DPC's Double Antibody Amphetamine assay. Each product is designed for the qualitative measurement of amphetamine in urine. Each product is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for amphetamine and its principal metabolites.

Method Comparison:

The IMMULITE Amphetamine procedure was compared to DPC's Double Antibody Amphetamine on a total of 160 urine samples from volunteer donors, presumed not to be drug abusers, and from a reference lab. The samples ranged from 200 to approximately 1000 ng/mL. A cutoff of 500 ng/mL was used for both procedures.

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IMMULITE Amphetamine

DAb Amphetamine	Positive	Negative
Positive	32	0	Relative sensitivity: 100%
Negative	3	125	Relative Specificity: 98%Agreement: 98%

IMMULITE Amphetamine was also compared to GC/MS results on 50 urine samples obtained similarly as above. The samples ranged from 6 to 1816 ng/mL on GC/MS. A cutoff of 500 ng/mL was used for both procedures.

IMMULITE Amphetamine

GC/MS	Positive	Negative
Positive	18	4
Negative	0	28

Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Amphetamine.

Eduard Reue

Edward M. Levine, Ph.D. Director of Clinical Affairs

12/17/99
Date

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol that resembles three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

'JAN 2 7 2000

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

Re: K992632

Trade Name: IMMULITE® Amphetamine Regulatory Class: II Product Code: DKZ Dated: December 17, 1999 Received: December 20, 1999

Dear Dr. Levine:

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 legally marketed predicate 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 regulations.

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Page 2

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" (21CFR 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/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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K 992632/5

K992632 510(k) Number (if known): Device Name: IMMULITE® Amphetamine

Indications For Use:

Jean

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992632

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).