510(k) · Cleared
ClearedFirst Sign Drug of Abuse Urine Screening Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.H.P.M., Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Jun 9, 2006 as substantially equivalent to K012300 (ACON Laboratories, Inc., 2001) and 5 other predicates after a 301-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jun 9, 2006
- Review
- 301 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K991079 (1999). 9 ancestors in all, the oldest K980249 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK991079 Accusign Bzo, Biosign Bzo, Status BzoPrinceton BioMeditech Corp. · 1999
- 1 generation backK012300 Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step…ACON Laboratories, Inc. · 2001
- This deviceK052197 First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991079 | Accusign Bzo, Biosign Bzo, Status Bzo | Princeton BioMeditech Corp. | 1999 | — |
| −1 | K012300 | Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step… | ACON Laboratories, Inc. | 2001 | — |
| 0 (this device) | K052197 | First Sign Drug of Abuse Urine Screening Test | W.H.P.M., Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012300 | Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test…Summary page 1…n Test Analyte Predicate Device Name Predicate Device 510(k)# Oxazeparn ACON BZO One Step Benzodiazepine Test Strip K012300 Oxycodone ACON OXY One Step Oxycodone Test Strip K043507 Secobarbital ACON BAR On… | 2001 |
| * | K043507 | Acon Oxy II One Step Oxycodone Test Strip; Test DeviceSummary page 1…Oxazeparn ACON BZO One Step Benzodiazepine Test Strip K012300 Oxycodone ACON OXY One Step Oxycodone Test Strip K043507 Secobarbital ACON BAR One Step Barbiturates Test Strip K050593 Methadone ACON MTD On… | 2005 |
| * | K050593 | Acon Bar II One Step Barbiturates Test Strip & DeviceSummary page 1…Oxycodone ACON OXY One Step Oxycodone Test Strip K043507 Secobarbital ACON BAR One Step Barbiturates Test Strip K050593 Methadone ACON MTD One Step Methadone test Strip K012595 Nortriptyline ACON TCA On… | 2005 |
| * | K012595 | Acon MTD One Step Methadone Test Strip and Test DeviceSummary page 1…Secobarbital ACON BAR One Step Barbiturates Test Strip K050593 Methadone ACON MTD One Step Methadone test Strip K012595 Nortriptyline ACON TCA One Step Tricyclic Antidepressants K02 1526 MDMA ACON MDMA… | 2001 |
| * | K021526 | Acon Tca One Step Tricyclic Antidepressant Test Strip and DeviceSummary page 1…Methadone ACON MTD One Step Methadone test Strip K012595 Nortriptyline ACON TCA One Step Tricyclic Antidepressants K02 1526 MDMA ACON MDMA One Step Ecstasy Test Strip K022589 ProductDescription The First Sign Drug… | 2002 |
| * | K022589 | Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test DeviceSummary page 1…ortriptyline ACON TCA One Step Tricyclic Antidepressants K02 1526 MDMA ACON MDMA One Step Ecstasy Test Strip K022589 ProductDescription The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of d… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 9 ancestors has a recall.
- 4 other devices also cite its predicate K012300.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below. This assay provides only a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas…
Read the full statement (146 words)
The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below.
This assay provides only a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For Professional Use Only.
First Sign Nortriptyline — nortriptyline — 1,000ng/mL
First Sign Secobarbital — secobarbital — 300ng/mL
First Sign MDMA — mdma — 5OOng/mL
First Sign Oxazepam — oxazepam — 300ng/mL
First Sign Oxycodone — oxycodone — I OOng/mL
First Sign Methadone — methadone — 300ng/mL
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052197: First Sign Drug of Abuse Urine Screening Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052197
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026