510(k) · Cleared

Cleared

Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136

K062025510(k) TraditionalCleared May 29, 2007315-day reviewClass II21 CFR 864.5700

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

Corgenix, Inc. · OBW 11-Dehydro Thromboxane B2 Kit, Urinary

Cleared on May 29, 2007 as substantially equivalent to K042423 (Accumetrics, Inc., 2004) after a 315-day review. Its family tree reaches back 2 generations to 1983.

Decided: May 29, 2007
Review: 315 days
Class: Class II
Product code: OBW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K830749 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK830749 Platelet AggregometerChrono-Log Corp. · 1983
1 generation backK042423 Verifynow-Aspirin AssayAccumetrics, Inc. · 2004
This deviceK062025 Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136Corgenix, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K830749	Platelet Aggregometer	Chrono-Log Corp.	1983	—
−1	K042423	Verifynow-Aspirin Assay	Accumetrics, Inc.	2004	—
0 (this device)	K062025	Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136	Corgenix, Inc.	2007	—

FIG. 1 — Lineage of K062025, 1983–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 OBW? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K042423	Verifynow-Aspirin Assay Summary page 1 …ification: 21 CFR 864 5700 Proposed Product Code: jo 0z L Predicate Device: VerifyNow~"' Aspirin Assay (K042423) Device Description: An ELISA for the detection of urinary 1I1-Dehydro Thromboxane B2 (I1 dhTxB 2). Goat anti-mouse IgG polyclon…	Accumetrics, Inc.	2004	—

Also cleared against K042423: 1 other device →

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?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 21.4 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K042423.

How does its category compare?

All OBW devices

OBW 11-Dehydro Thromboxane B2 Kit, Urinary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · OBW

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBW

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

Recalls per year · OBW

No recall names OBW since 2007.

Adverse event reports per year · OBW

2in 2023

2007high 3 (2016) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	1
2016	0	—	3
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	2
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B 2 (I1 dhTxB 2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only. The AspirinWorks® Test Kit is intended for use in clinical (hospital and reference) laboratories. The AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) to determine…

Read the full statement (110 words)

The AspirinWorks® Test Kit is intended for use in clinical (hospital and reference) laboratories.

The AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (1ldhTxB 2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.

The AspirinWorks® Test Kit is intended for use in clinical (hospital and reference) laboratories.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062025: Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062025

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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