510(k) · Cleared

Cleared

PF4 Enhanced assay

K201570510(k) SpecialCleared Sep 11, 202092-day reviewClass II21 CFR 864.7695

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

Immucor Gti Diagnostics, Inc. · LCO Platelet Factor 4 Radioimmunoassay

Cleared on Sep 11, 2020 as substantially equivalent to K053559 (Genetic Testing Institute, 2006) after a 92-day review. Its family tree reaches back 2 generations to 1999.

Decided: Sep 11, 2020
Review: 92 days
Class: Class II
Product code: LCO
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K983379 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK983379 Gti-PF4 ElisaGenetic Testing Institute · 1999
1 generation backK053559 PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 2006 · Recalled
This deviceK201570 PF4 Enhanced assayImmucor Gti Diagnostics, Inc. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K983379	Gti-PF4 Elisa	Genetic Testing Institute	1999	—
−1	K053559	PF4 Enhanced Solid Phase Elisa	Genetic Testing Institute	2006	2
0 (this device)	K201570	PF4 Enhanced assay	Immucor Gti Diagnostics, Inc.	2020	—

FIG. 1 — Lineage of K201570, 1999–2020Source: 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 LCO? 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 LCO device

#1 K243374 HemosIL CL HIT-IgG (PF4-H)score 9.7 · 4 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

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
*	K053559	PF4 Enhanced Solid Phase Elisa Summary page 4 …LCO Establishment Registration Number: 2183608 4. Name of Predicate Device for Claiming Equivalence PF4 Enhanced Assay (K053559) 5. Description of Device PF4 Enhanced Assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 Enhanced EL…	Genetic Testing Institute	2006	2

Also cleared against K053559: 2 other devices →

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 21 years and passes through 2 companies; a new generation was cleared every 14.6 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K053559.

How does its category compare?

All LCO devices

LCO Platelet Factor 4 Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · LCO

1in 2025

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCO

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

Recalls per year · LCO

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LCO

11in 2025

2007high 11 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	2	0
2012	0	—	0	0
2013	0	—	1	0
2014	0	—	1	0
2015	0	—	0	0
2016	1	—	0	2
2017	1	—	0	0
2018	0	—	0	0
2019	0	—	0	4
2020	2	—	0	1
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	2
2025	1	—	0	11
2026	0	—	3 (2)	—

What is it indicated for?

PF4 Enhanced assay is designed as a solid phase enzyme linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hematology, coagulation, or other pathology laboratories to assist in screening patient samples, 3.2% sodium citrate (plasma) or without anticoagulant (serum), for the presence of heparin associated commonly found in patients with heparin induced thrombocytopenia (HIT) or thrombosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201570 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201570: PF4 Enhanced assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201570

Report an extraction error

Are you the manufacturer?

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