# K983703: Modification to Abuscreen Online for Methadone

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Dec 11, 1998 after 51 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930928 (1993). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930928: Roche Abuscreen Online for Methadone, Roche Diagnostic Systems, Inc. (1993) Summary page 2.

## Most influential descendants
- K021505: Online Dat II Methadone II (2002), 3 descendants of its own
- K253491: ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (2026), 0 descendants of its own
- K253490: Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (2026), 0 descendants of its own
- K220134: cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (2022), 0 descendants of its own

## Indications for use
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of methadone use or abuse.

Source page: https://510kreport.com/device/K983703
Methodology: https://510kreport.com/methodology