# K973784: Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Dec 3, 1997 after 61 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K012396: Ontrak Testcard 9 (2001), 1 descendant of its own
- K060791: Triage Tox Drug Screen, Model 94400 (2006), 0 descendants of its own
- K051235: ON Trak Testcard (2005), 0 descendants of its own

## Recalls of this device
- Nov 14, 2017 · Class II · Z-0418-2018: The recalled lots have demonstrated unexpected false positive THC results.
- Jan 4, 2012 · Not classified · Z-1130-2012: Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.
- Jul 1, 2011 · Not classified · Z-0521-2012: The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928.
- Nov 6, 2008 · Not classified · Z-1088-2009: The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has 

## Indications for use
The Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants - Opiates 2000 (and other forms of the product) is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates, and Tricyclic Antidepressants in urine. This test provides only a preliminary test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The tricyclic test is a qualitative screening test. A negative result does not eliminate the possibility of the presence of tricyclic antidepressants in the urine specimen at concentrations lower than 1000 ng/mL. Should confirmation of the test result for the parent compound or the metabolites be desired, an alternative method that is capable of identification and quantification should be used, e.g. HPLC, GC or GC/MS. A positive screening result may be due to the sum of the reactivity of the parent tricyclic antidepressant and the various metabolites of the respective compound.

Source page: https://510kreport.com/device/K973784
Methodology: https://510kreport.com/methodology