PMA · Approved

Approved

Immunocytochemical Assay to Detect Progesterone

P920006PMAApproved Sep 26, 19951,328-day reviewClass III21 CFR 864.1860

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

Abbott Laboratories · LPI Kit, Assay, Progesterone Receptor

Approved on Sep 26, 1995 through premarket approval, which rests on the device’s own clinical evidence after a 1,328-day review. 3 later devices descend from it.

Decided: Sep 26, 1995
Review: 1,328 days
Class: Class III
Product code: LPI
Recalls: None

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

This deviceP920006 Immunocytochemical Assay to Detect ProgesteroneAbbott Laboratories · 1995
Descendant · cites it directly · 2 of its ownK990618 Ventana PGR Primary Antibody (Clone 1A6)Ventana Medical Systems, Inc. · 1999 · Recalled
Descendant · 2 generations on · 0 of its ownK061360 Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody…Lab Vision Corp. · 2006
Descendant · 2 generations on · 0 of its ownK012960 Biogenex Monoclonal Anti-Progesterone ReceptorBiogenex Laboratories · 2002

Most influential descendants

Showing 3 of 3 · See all

K990618Ventana PGR Primary Antibody (Clone 1A6)Ventana Medical Systems, Inc. · 1999 · cites it directly2descendants
K061360Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1)Lab Vision Corp. · 2006 · 2 generations on0descendants
K012960Biogenex Monoclonal Anti-Progesterone ReceptorBiogenex Laboratories · 2002 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	P920006	Immunocytochemical Assay to Detect Progesterone	Abbott Laboratories	1995	—
+1	K990618	Ventana PGR Primary Antibody (Clone 1A6)	Ventana Medical Systems, Inc.	1999	2
+2	K061360	Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1)	Lab Vision Corp.	2006	—
+2	K012960	Biogenex Monoclonal Anti-Progesterone Receptor	Biogenex Laboratories	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2006	1	0

FIG. 1 — Lineage of P920006, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPI? 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

Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990618	Ventana PGR Primary Antibody (Clone 1A6)	Ventana Medical Systems, Inc.	1999	2

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, K990618 (Ventana Medical Systems, Inc., 1999) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LPI devices

LPI Kit, Assay, Progesterone Receptor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPI

FDA has decided no LPI device since 2007.

Median 510(k) review, days · LPI

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

Recalls per year · LPI

No recall names LPI since 2007.

Adverse event reports per year · LPI

No MAUDE report names LPI since 2007.

View these four charts as a table

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

https://510kreport.com/device/P920006 · printed Nov 4, 2026

Cite this page

510(k) Report. “P920006: Immunocytochemical Assay to Detect Progesterone.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P920006

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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