510(k) Report

510(k) · Cleared

Cleared

T-TEK

K050817510(k) TraditionalCleared Dec 12, 2005256-day reviewClass II21 CFR 864.7875

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

R2 Diagnostics, Inc. · GJA Test, Thrombin Time

Cleared on Dec 12, 2005 as substantially equivalent to K884384 (American Bioproducts Co., 1988) after a 256-day review. Its family tree reaches back 1 generation to 1988.

Decided
Dec 12, 2005
Review
256 days
Class
Class II
Product code
GJA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K884384 (1988). No later device cites it as a predicate yet.

K884384 · Thrombin-Prest Reagent Kit · American Bioproducts Co. · 198819851990199520002005
K884384 · Thrombin-Prest Reagent Kit · American Bioproducts Co. · 19880
  1. Root · 1 generation backK884384 Thrombin-Prest Reagent KitAmerican Bioproducts Co. · 1988
  2. This deviceK050817 T-TEKR2 Diagnostics, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884384Thrombin-Prest Reagent KitAmerican Bioproducts Co.1988—
0 (this device)K050817T-TEKR2 Diagnostics, Inc.2005—
FIG. 1 — Lineage of K050817, 1988–2005Source: 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), 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 GJA? 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
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K884384Thrombin-Prest Reagent Kit
Summary page 1
…Test, thrombin time (per 21 CFR section 864.7875) Comparison Device: STA Thrombin, K884384 Description of the Device and Intended Use The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in…
American Bioproducts Co.1988—

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?

  • Its one ancestor has no recall.

How does its category compare?

All GJA devices

GJA Test, Thrombin Time: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GJA

FDA has decided no GJA device since 2007.

Median 510(k) review, days · GJA

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

Recalls per year · GJA

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GJA

2in 2023

2012: 22015: 12017: 102023: 2
2007high 10 (2017) · low 0 (2007)2025

MAUDE reports naming product code GJA, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—02
20130—00
20140—00
20150—01
20160—00
20170—110
20180—00
20190—00
20200—00
20210—00
20220—00
20230—02
20240—00
20250—00
20260—0—

What is it indicated for?

The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

Indications for use as stated in the FDA summary.

More from R2 Diagnostics, Inc.

10 FDA decisions under this applicant name. See the company

  • K102908Nofact IXR2 Diagnostics, Inc. · 2011
  • K102851Nofact ViiiR2 Diagnostics, Inc. · 2011
  • K090105Lupotek KCTR2 Diagnostics, Inc. · 2010
  • K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc. · 2010
  • K082631Thrombo Tek Pse, Model 90-480R2 Diagnostics, Inc. · 2008

Recent decisions in GJA

The GJA category page

  • K982209Accuclot Thrombin Time Reagent Model A8713/A4589Sigma Diagnostics, Inc. · 1998
  • K970645BC Thrombin ReagentBehring Diagnostics, Inc. · 19972 recalls
  • K925493Biomerieux Hemolab Thrombicalci-TestBiomerieux Vitek, Inc. · 1994
  • K930157Test ThrombinBehring Diagnostics, Inc. · 1993
  • K923220Thrombin Clot Time Test ProcedureMedical Laboratory Automation Systems, Inc. · 1992

https://510kreport.com/device/K050817 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050817: T-TEK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050817

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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