K Number
K992634
Device Name
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
Date Cleared
2000-01-20

(167 days)

Product Code
Regulation Number
862.3610
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IMMULITE® Methamphetamine is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and designed for the qualitative measurement of methamphetamine 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 methamphetamine. A cutoff of 500 ng/mL is used by the IMMULITE Methamphetamine assay to identify positive and negative results.
Device Description
IMMULITE® Methamphetamine is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer.
More Information

Not Found

No
The device description and performance studies focus on a standard immunoassay technology and do not mention any AI or ML components.

No
This device is an in vitro diagnostic immunoassay for the qualitative measurement of methamphetamine in urine, intended to identify positive and negative results, not to treat a condition.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended strictly for in vitro diagnostic use in clinical laboratories."

No

The device description explicitly states it is a "solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer," indicating it is a hardware-based in vitro diagnostic device, not software-only.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "It is intended strictly for in vitro diagnostic use in clinical laboratories..."

This statement clearly identifies the device as an in vitro diagnostic product.

N/A

Intended Use / Indications for Use

IMMULITE® Methamphetamine is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and designed for the qualitative measurement of methamphetamine 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 methamphetamine. A cutoff of 500 ng/mL is used by the IMMULITE Methamphetamine assay to identify positive and negative results.

Product codes (comma separated list FDA assigned to the subject device)

LAF

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Method Comparison: IMMULITE Methamphetamine was compared to DPC's Coat-A-Count (CAC) Methamphetamine on 214 urine samples from volunteer donors, presumed not to be drug abusers, and a reference lab. The samples ranged from undetectable to approximately 1500 ng/mL (3 times the cutoff value). A cutoff of 500 ng/mL was used for both procedures.

IMMULITE Methamphetamine was also compared to GC/MS on 37 urine samples obtained similarly as above. The samples ranged from 212 ng/mL to 972 ng/mL on GC/MS. A cutoff of 500 ng/mL was used for both procedures.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Against CAC Methamphetamine: Relative sensitivity: 92%, Relative Specificity: 100%, Agreement: 97%.
Against GC/MS: Sensitivity: 88%, Specificity: 86%, Agreement: 87%.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K885071

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.3610 Methamphetamine test system.

(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).

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K992634

JAN 2 0 2000

510 (k) Summary Safety and Effectiveness

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

Name:Diagnostic Products Corporation
Address:5700 West 96th Street
Los 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:November 29, 1999
Device Name:
Trade:IMMULITE® Methamphetamine
Catalog Number:LKMA1 (100 tests), LKMA5 (500 tests)
CFR: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.
Common:Reagent system for the determination of methamphetamine
in urine.
Classification:Class II device, 91-DKZ (21 CFR 862.3100)
Panel:Toxicology
CLIA Complexity Category:We believe the category to be moderate, based on previous
classification of analogous tests.
Manufacturer:Diagnostic Products Corporation (DPC)
5700 West 96th Street
Los Angeles, CA 90045-5597

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Establishment Registration #:

DPC's establishment Registration No. is 2017183

| Substantially Equivalent

Predicate Device:DPC's Coat-A-Count Methamphetamine (K885071)
Description of Device:IMMULITE® Methamphetamine is a solid-phase,
chemiluminescent enzyme immunoassay for use with the
IMMULITE® Automated Analyzer.
Intended Use of the
Device:IMMULITE® Methamphetamine is a solid-phase,
chemiluminescent enzyme immunoassay for use with the
IMMULITE Automated Analyzer and designed for the
qualitative measurement of methamphetamine 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 methamphetamine. A
cutoff of 500 ng/mL is used by the IMMULITE
Methamphetamine assay to identify positive and negative
results.

Summary and Explanation of the test:

Methamphetamine is a potent sympathomimetic amine capable of stimulating the central nervous system with less peripheral actions than amphetamine. It is structurally similar to amphetamine and methylphenidate and, like them, acts through increasing the release of norepinephrine as well as through direct stimulation of postsynaptic norepinephrine receptors. There are two stereoisomers: d-methamphetamine is 10 times more potent as a CNS stimulant than I-methamphetamine, while I-methamphetamine (I-desoxyephedrine) is used in nasal inhalers for peripheral vasoconstriction Amphetamines induce euphoria, irritability and anxiety. Tolerance and dependence have been observed.

Methamphetamine is metabolized to the active metabolite, amphetamine, hydroxylated metabolites and deaminated to hippuric and benzoic acid. It is a metabolite of benzphetamine and selegiline. About 70% of a dose is excreted in the urine in 24 hours. Methamphetamine is excreted primarily unchanged (44% to 76%) with a small fraction as 4-hydroxymethamphetamine (15%) or amphetamine (6%). The half-life of methamphetamine varies from 12 to 34 hours and is a function of urinary pH. The excretion of unchanged methamphetamine is increased in acidic urine, while in alkaline urine it is reduced to less than 5% of the dose. After a single 10 mg dose, urine concentrations ranged from 0.5 to 4.0 µg/mL in the first 24 hours. After chronic administration, methamphetamine concentrations of 25 to 300 µg/mL and amphetamine concentrations of 1 to 90 ug/mL are found in urine. However, the length of time

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following drug use for which a positive result may occur is dependent upon several factors including the frequency and amount of drug, metabolic rate, excretion rate, drug half-life, and the drug user's age, weight, activity, and diet.

Technological Comparison to Predicate:

Methamphetamine is a solid-phase, chemiluminescent enzyme IMMULITE immunoassay. The solid-phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a monoclonal antibody specific for methamphetamine.

The patient sample and alkaline phosphatase-conjugated methamphetamine are simultaneously introduced into the Test Unit and incubated for approximately 30 minutes at 37 ℃ with intermittent agitation. During this time, methamphetamine in the sample competes with enzyme-labeled methamphetamine 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 methamphetamine 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.

The Coat-A-Count Methamphetamine procedure is a solid-phase radioimmunoassay, wherein 1331-labeled methamphetamine competes for a fixed time with methamphetamine in the patient sample for methamphetamine-specific antibody sites. Because the antibody is immobilized to the wall of a polypropylene tube, simply decanting the supernatant suffices to terminate the competition and to isolate the antibody-bound fraction of the radiolabeled methamphetamine, which is then counted in a gamma counter. The Qualitative Procedure vields positive and negative results relative to a reference chosen as a cutoff.

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Performance Equivalence:

Diagnostic Products Corporation asserts that the IMMULITE® Methamphetamine substantially equivalent results to other commercially marketed produces methamphetamine assays, such as the Coat-A-Count Methamphetamine assay. Each product is designed for the qualitative measurement of methamphetamine in urine. Each product is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for methamphetamine.

Method Comparison:

IMMULITE Methamphetamine was compared to DPC's Coat-A-Count (CAC) Methamphetamine on 214 urine samples from volunteer donors, presumed not to be drug abusers, and a reference lab. The samples ranged from undetectable to approximately 1500 ng/mL (3 times the cutoff value). A cutoff of 500 ng/mL was used for both procedures.

IMMULITE Methamphetamine

CAC MethamphetaminePositiveNegativeRelative sensitivity:92%
PositiveRelative Specificity:100%
Negativeાર્ રAgreement:97%

IMMULITE Methamphetamine was also compared to GC/MS on 37 urine samples obtained similarly as above. The samples ranged from 212 ng/mL to 972 ng/mL on GC/MS. A cutoff of 500 ng/mL was used for both procedures.

IMMULITE Methamphetamine

GC/MSPositiveNegativeSensitivity:88%
Positive142Specificity:86%
Negative318Agreement:87%

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® Methamphetamine.

Edward Levin

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

1/29/99

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" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing right, with flowing lines beneath them, possibly representing water or movement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 0 2000

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

Re: K992634

Trade Name: IMMULITE® Methamphetamine Regulatory Class: II Product Code: LAF Dated: November 29, 1999 Received: November 30, 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 (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 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

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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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16992634 510(k) Number (if known): Device Name: IMMULITE® Methamphetamine

Indications For Use:

IMMULITE® Methamphetamine is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and designed for the qualitative measurement of methamphetamine 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 methamphetamine. A cutoff of 500 ng/mL is used by the IMMULITE Methamphetamine assay to identify positive and negative results

(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)