510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Fibrinogen Screen

K800826510(k) TraditionalCleared May 30, 198046-day reviewClass II21 CFR 864.7340Recalls 2

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

Pacific Hemostasis · KQJ System, Fibrinogen Determination

Cleared on May 30, 1980 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided
May 30, 1980
Review
46 days
Class
Class II
Product code
KQJ
Recalls
2
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared19801990200020102020
  1. This deviceK800826 Fibrinogen ScreenPacific Hemostasis · 1980
  2. Descendant · cites it directly · 0 of its ownK060968 Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium…Wortham Laboratories, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K800826Fibrinogen ScreenPacific Hemostasis1980—
+1K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride…Wortham Laboratories, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K800826, 1980–2007Source: 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 KQJ? 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 KQJ device

  1. #1 K251968 HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLscore 10.0 · 2 generations · no Class I recall
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
K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc.20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 19, 2017Class IIZ-2762-2017Under Investigation by firmAn issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater…
May 19, 2017Class IIZ-2763-2017Under Investigation by firmAn issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K060968 (Wortham Laboratories, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KQJ devices

KQJ System, Fibrinogen Determination: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQJ

1in 2025

2007: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KQJ

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

Recalls per year · KQJ

No recall names KQJ since 2007.

Adverse event reports per year · KQJ

2in 2024

2007: 12015: 12019: 12021: 12024: 2
2007high 2 (2024) · low 0 (2008)2025

MAUDE reports naming product code KQJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—01
20200—00
20210—01
20220—00
20230—00
20240—02
20251—00
20260—0—

More from Pacific Hemostasis

29 FDA decisions under this applicant name. See the company

  • K000679Thrombostrate Control PlasmasPacific Hemostasis · 2000
  • K994100Pacific Hemostasis Thromboplastin DPacific Hemostasis · 20002 recalls
  • K992130Pacific Hemostasis Thromboscreen 400CPacific Hemostasis · 1999
  • K992279Heparin Control Plasma Level 2Pacific Hemostasis · 1999
  • K992278Heparin Control Plasma Level 1Pacific Hemostasis · 1999

Recent decisions in KQJ

The KQJ category page

  • K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co. · 2025
  • K073367Hemosil Fibrinogen-CInstrumentation Laboratory CO · 2007
  • K050928Dade Thrombin ReagentDade Behring, Inc. · 2005
  • K971858Sigma Diagnostics Fibrinogen Kit (886A/887A)Sigma Diagnostics, Inc. · 1997
  • K970189FIF TMPanbio, Inc. · 1997

https://510kreport.com/device/K800826 · printed Nov 6, 2026

Cite this page

510(k) Report. “K800826: Fibrinogen Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800826

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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