510(k) Report

510(k) · Cleared

Cleared

Coat-a-Count Methamphetamin #TKMA1

K885071510(k) TraditionalCleared Jan 9, 198932-day reviewClass II21 CFR 862.3610

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diagnostic Products Corp. · LAF Gas Chromatography, Methamphetamine

Cleared on Jan 9, 1989 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jan 9, 1989
Review
32 days
Class
Class II
Product code
LAF
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1990200020102020
  1. This deviceK885071 Coat-a-Count Methamphetamin #TKMA1Diagnostic Products Corp. · 1989
  2. Descendant · cites it directly · 0 of its ownK992634 Immulite Methamphetamine, Model LKMA1, LKMA5Diagnostic Products Corp. · 2000

Most influential descendants

Showing 1 of 1 · See all
  • K992634Immulite Methamphetamine, Model LKMA1, LKMA5Diagnostic Products Corp. · 2000 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K885071Coat-a-Count Methamphetamin #TKMA1Diagnostic Products Corp.1989—
+1K992634Immulite Methamphetamine, Model LKMA1, LKMA5Diagnostic Products Corp.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K885071, 1989–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LAF device

  1. #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992634Immulite Methamphetamine, Model LKMA1, LKMA5Diagnostic Products Corp.20000

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?

  • Of its descendants, K992634 (Diagnostic Products Corp., 2000) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LAF devices

LAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAF

2in 2021

2008: 22011: 42012: 22014: 22015: 32016: 12017: 12020: 12021: 2
2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LAF

43in 2015

2011: 345 days median2015: 43 days median
2007high 345 (2011) · low 43 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LAF

No recall names LAF since 2007.

Adverse event reports per year · LAF

No MAUDE report names LAF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—00
20100—00
2011434500
20122—00
20130—00
20142—00
201534300
20161—00
20171—00
20180—00
20190—00
20201—00
20212—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in LAF

The LAF category page

  • K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021
  • K201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron Group · 2020
  • K170222Rapid Tox Cup IIAmerican Bio Medica Corp. · 2017
  • K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2016

https://510kreport.com/device/K885071 · printed Nov 4, 2026

Cite this page

510(k) Report. “K885071: Coat-a-Count Methamphetamin #TKMA1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K885071

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026