(147 days)
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No
The summary describes a fluorescence immunoassay and its performance characteristics, with no mention of AI, ML, or related concepts.
No
The device is an immunoassay intended for in vitro diagnostic (IVD) use to detect drug metabolites in urine, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine," which directly indicates its role in diagnosing the presence of these substances.
No
The device description explicitly states it is a "fluorescence immunoassay" and is intended for use with the "Triage® Meter," indicating it is a physical assay kit and a hardware meter, not a software-only device.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative or qualitative determination of major metabolites of [various drugs] in urine." This involves testing a biological sample (urine) in vitro (outside the body) to provide diagnostic information (presence and level of drug metabolites).
- Device Description: The description reiterates the same purpose of determining substances in urine.
- Performance Studies: The performance studies describe analytical sensitivity, interfering substances, specificity/cross-reactivity, and imprecision, all of which are standard evaluations for IVD devices.
- Comparison to Reference Methods: The comparison to GC/MS and HPLC are comparisons to established analytical methods used in clinical laboratories for drug testing, further supporting its role as a diagnostic tool.
The term "In Vitro Diagnostic" directly applies to devices that examine specimens taken from the human body to provide information for diagnostic purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The Triage® TOX Drug Screen is a fluorescence immunoassay intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.
The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage® Meter for the point-of-care semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.
Product codes
DKZ, DIO, LDJ, DJG, DIG, DIG, JXM, LAF, LCM, MLK
Device Description
The Triage® TOX Drug Screen is a fluorescence immunoassay intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Urine
Indicated Patient Age Range
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Intended User / Care Setting
Point-of-care
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Sensitivity: In all cases, the analytical sensitivity was below the reportable range of the test.
Interfering Substances: Substances that are commonly in human urine were tested for interference with results in samples spiked with drug 25% above the threshold concentration and samples spiked with drug 25% below the threshold concentration. None of the substances tested caused interference with the assay results.
Specificity/Cross-reactivity: Drugs and related substances were added to drug-free urine and tested using the Triage® TOX Drug Screen to determine the concentration that produces a positive result. The results are described in the labeling.
Imprecision: Imprecision was determined by measuring three contrived specimens with drug added at approximately 25% below the threshold concentration, the threshold concentration, and 25% above the threshold concentration. Each specimen was evaluated at three external sites by individuals without training as clinical laboratorians. The within-day and total imprecision for each analyte are described in the labeling.
Previously established thresholds (amphetamines 1000, Threshold: methamphetamines 1000, barbiturates 300, benzodiazepines 300, tricyclic antidepressants 1000, phencyclidine 25, opiates 300, cocaine 300, and THC 50) were challenged by testing specimens containing each drug or drug metabolite spiked into drug-free urine at concentrations in increments of 25% above and 25% below the threshold. Each specimen was tested using the Triage® TOX Drug Screen. The data paralleled the expected agreement based on the coefficient of variation of the assays.
The results of performance studies demonstrate that the Triage® TOX Drug Screen is a safe and effective method for the semi-quantitative or qualitative evaluation of drugs of abuse in urine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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510(k) Summary of Safety and Effectiveness
JAN 1 0 2002
Triage® TOX Drug Screen
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
(To be determined) 510(k) Number:
A. Name and Address of Submitter
| Company Name: | Biosite Incorporated |
|---|---|
| Address: | 11030 Roselle Street |
| San Diego, CA 92121 | |
| Telephone: | (858) 455-4808 |
| Fax: | (858) 535-8350 |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 8/15/01 |
B. Device Names
-
- Trade Name
Triage® TOX Drug Screen
-
- Common / Usual Name
Test System for Drugs of Abuse
- Common / Usual Name
3. Classification Name
Amphetamıne test system
Barbiturate test system
Benzodiazepine test system
Cocaine and cocaine metabolite test system
Opiate test system
Cannabinoid test system
Methamphetamine test system
Tricyclic antidepressant drugs test system
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(Note: Phencyclidine test system the phencyclidine test system has not been classified but has the same intended use to measure phencyclidine in serum or urine.
C. Predicate Devices
Comparison to reference methods such as GC/MS and HPLC.
D. Device Description and Intended Use
The Triage® TOX Drug Screen is a fluorescence immunoassay intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.
E. Summary of Performance Data
Analytical Sensitivity: In all cases, the analytical sensitivity was below the reportable range of the test.
Interfering Substances: Substances that are commonly in human urine were tested for interference with results in samples spiked with drug 25% above the threshold concentration and samples spiked with drug 25% below the threshold concentration. None of the substances tested caused interference with the assay results.
Specificity/Cross-reactivity: Drugs and related substances were added to drug-free urine and tested using the Triage® TOX Drug Screen to determine the concentration that produces a positive result. The results are described in the labeling.
Imprecision: Imprecision was determined by measuring three contrived specimens with drug added at approximately 25% below the threshold concentration, the threshold concentration, and 25% above the threshold concentration. Each specimen was evaluated at three external sites by individuals without training as clinical laboratorians. The within-day and total imprecision for each analyte are described in the labeling.
Previously established thresholds (amphetamines 1000, Threshold: methamphetamines 1000, barbiturates 300, benzodiazepines 300, tricyclic antidepressants 1000, phencyclidine 25, opiates 300, cocaine 300, and THC 50) were challenged by testing specimens containing each drug or drug metabolite spiked into drug-free urine at concentrations in increments of 25%
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above and 25% below the threshold. Each specimen was tested using the Triage® TOX Drug Screen. The data paralleled the expected agreement based on the coefficient of variation of the assays.
F. Conclusion
The results of performance studies demonstrate that the Triage® TOX Drug Screen is a safe and effective method for the semi-quantitative or qualitative evaluation of drugs of abuse in urine.
11.000
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 5 2002
Jeffery R. Dahlen, Ph.D. Principal Scientist Clinical & Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Diego, CA 92121
Re:
Trade/Device Name: Triage® TOX Drug Screen Trade/Device Namber: 21 CFR 862.3100; 21 CFR 862.3250; 21 CFR 862.3870;
Regulation Number: 21 CFR 862.3100; 21 CFR 862.3250; 21 CFR 862.3870; 21 CFR 862.3650; 21 CFR 862.3150; 21 CFR 862.3170; 21 CFR 862.3610; 21CFR 862.3910 Regulation Name: Amphetamine test system; Cocaine and cocaine metabolite test system; Cannabinoid test system; Opiate test system; Barbiturate test system; Benzodiazepine test system; Darbhamphetamine test system; Tricyclic antidepressant test system Regulatory Class: Class II Regulatory Class: Class: Class II
Product Code: DKZ; DIO; LDJ; DJG; DIG; DIG; JXM; LAF; LCM; MLK Dated: November 16, 2001
Received: November 19, 2001
Dear Dr. Dahlen:
This letter corrects the substantially equivalent letter dated January 10, 2002, regarding the I his letter corrects the substantially equit regulation name and the incorrect indications for use.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) prematially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard manative te of the Medical Device American Car to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been icelassified in accessor al of a premarket approval application (PMA). and Cosment Act (Act) that to not require approvial controls provisions of the Act. The You may, therefore, thanket the devices, bet include requirements for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) and existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of I casts oncerning your device in the Federal Register.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device of your device to a legally marketed notification. The FDA finding of Substantal equivalice or 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 1
0 Carles of Comment of Callers) and makes been assesses the Office of Complian If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in vitro diagnostic consists on the promotion and advertising of your device, and (301) 594-4588. Additionally, for questions on are projects . Also, please note the regulation please contact the Office of Compitation at (301) of TV (21CFR 807.97). Other general
entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other ge entitled, "Misbranding by relefence to picmarse of rived from the Division of Small
information on your responsibilities under the Act may be obtains of Small information on your responsibilities under and its toll-free mumber (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-free munder (800)" Manufacturers International and Consumer Prissiblance and Collection of the Sun anain.html".
(301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.
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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Page 1 of 1
510(k) Number (if known): (to be determined) K012745
Device Name: Triage® TOX Drug Screen
Indications For Use:
The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be
r and the seen is a fluorescence intent of care semi quantitative or The Triage TOX Drug Screen is a labor-of-care sem-quantitative or used with the Thage "Meter for the personites of amphetamines, qualitative determination of major metabolitos ones, cocaine, opiates,
methamphetamines, barbituralis, benzodiazepines, cocaine, opiates, methamplietamines, barbiturates, benast in urine.
Dan Coray
(Division Sign-Off)
Division of Clinical Laboratory De 510(k) Number .
(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)
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