510(k) Report

510(k) · Cleared

Cleared

N/T Protein Control PY

K951012510(k) TraditionalCleared Apr 17, 199542-day reviewClass II21 CFR 864.7340

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

Behring Diagnostics, Inc. · GIL Plasma, Fibrinogen Control

Cleared on Apr 17, 1995 after a 42-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
Apr 17, 1995
Review
42 days
Class
Class II
Product code
GIL
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared2003: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951012 N/T Protein Control PYBehring Diagnostics, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK963292 Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK031650 Ferritin Generation 2Roche Diagnostics Corp. · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · cites it directly1descendant
  • K031650Ferritin Generation 2Roche Diagnostics Corp. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951012N/T Protein Control PYBehring Diagnostics, Inc.1995—
+1K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.19962
+2K031650Ferritin Generation 2Roche Diagnostics Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200310
FIG. 1 — Lineage of K951012, 1995–2003Source: 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.

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  • Recall history across each candidate’s familyin the report
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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
K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.19961

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, K963292 (Roche Diagnostic Systems, Inc., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GIL devices

GIL Plasma, Fibrinogen Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GIL

FDA has decided no GIL device since 2007.

Median 510(k) review, days · GIL

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

Recalls per year · GIL

No recall names GIL since 2007.

Adverse event reports per year · GIL

No MAUDE report names GIL 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 Behring Diagnostics, Inc.

146 FDA decisions under this applicant name. See the company

  • K973832Opus HLH ControlsBehring Diagnostics, Inc. · 1997
  • K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
  • K972840N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
  • K973202Modification of Opus Ferritin Test SystemBehring Diagnostics, Inc. · 1997
  • K972316Opus D-DimerBehring Diagnostics, Inc. · 1997

Recent decisions in GIL

The GIL category page

  • K962407N/T Protein Control PYBehring Diagnostics, Inc. · 1996
  • K946193Fibrinogen Control (Human) Level 1, 2, 3More Diagnostics · 1995
  • K946265Fibrinogen High Abnormal Control - Level 3Clinical Controls, Inc. · 1995
  • K935598Plasma Fibrinogen Control Level 1/Level 2Clinical Controls, Inc. · 1995
  • K934741Liquid Fibrinogen FDP Control Level 1 & 2Clinical Controls, Inc. · 1994

https://510kreport.com/device/K951012 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951012: N/T Protein Control PY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951012

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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