510(k) Report

510(k) · Cleared

Cleared

Cobas FP Reagen for Primidone & Primi Calibrators

K852318510(k) TraditionalCleared Jun 25, 198525-day reviewClass II21 CFR 862.3680

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

Roche Diagnostic Systems, Inc. · LFT Fluorescent Immunoassay, Primidone

Cleared on Jun 25, 1985 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 25, 1985
Review
25 days
Class
Class II
Product code
LFT
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK852318 Cobas FP Reagen for Primidone & Primi CalibratorsRoche Diagnostic Systems, Inc. · 1985
  2. Descendant · cites it directly · 1 of its ownK031856 Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp. · 2003 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK091617 QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp. · 2003 · cites it directly1descendant
  • K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852318Cobas FP Reagen for Primidone & Primi CalibratorsRoche Diagnostic Systems, Inc.1985—
+1K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp.20032
+2K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200910
FIG. 1 — Lineage of K852318, 1985–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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? (2)

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

NumberDeviceApplicantDecidedDescendants
K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp.20031

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, K031856 (Roche Diagnostics Corp., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LFT devices

LFT Fluorescent Immunoassay, Primidone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFT

FDA has decided no LFT device since 2007.

Median 510(k) review, days · LFT

Too few LFT 510(k)s in any year since 2007 to give a median.

Recalls per year · LFT

No recall names LFT since 2007.

Adverse event reports per year · LFT

No MAUDE report names LFT since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Roche Diagnostic Systems, Inc.

296 FDA decisions under this applicant name. See the company

  • K983698Modification to Abuscreen Online BarbituratesRoche Diagnostic Systems, Inc. · 1999
  • K983702Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999
  • K983704Modification to Abuscreen Online for PhencyclidineRoche Diagnostic Systems, Inc. · 1999
  • K983556Abuscreen Online Benz 300 CalibratorsRoche Diagnostic Systems, Inc. · 1998
  • K983555Abuscreen Online Benz 200 CalibratorsRoche Diagnostic Systems, Inc. · 1998

Recent decisions in LFT

The LFT category page

  • K950028Primidone Fpia Reagent Set and CalibratorsSigma Diagnostics, Inc. · 1995
  • K904683Stratus Primidone Fluorometric EnzymeBaxter Healthcare Corp · 1990
  • K895567Primidone (Fpia) KitTudor Laboratories, Inc. · 1989
  • K842196Stratus Primidone Florometric EnzyAmerican Dade · 1984
  • K823741Advance Emit-Aed Primedone AssaySyva Co. · 1983

https://510kreport.com/device/K852318 · printed Nov 5, 2026

Cite this page

510(k) Report. “K852318: Cobas FP Reagen for Primidone & Primi Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K852318

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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