510(k) · Cleared

Cleared

Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070), Progesterone Calibrators (Gem.C070)

K972133510(k) TraditionalCleared Jun 24, 199718-day reviewClass I21 CFR 862.1620

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

Johnson & Johnson Clinical Diagnostics, Inc. · JLS Radioimmunoassay, Progesterone

Cleared on Jun 24, 1997 after an 18-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Jun 24, 1997
Review: 18 days
Class: Class I
Product code: JLS
Recalls: None
Predicates: 0

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

This deviceK972133 Vitros Immunodiagnostics Products Progesterone Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997
Descendant · cites it directly · 1 of its ownK022901 Vitros Immunodiagnostic Products Progesterone Reagent Pack and…Ortho-Clinical Diagnostics · 2002
Descendant · 2 generations on · 0 of its ownK032296 Vitros Immunodiagnostic Products Progestrone Reagent Pack and…Ortho-Clinical Diagnostics, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K022901Vitros Immunodiagnostic Products Progesterone Reagent Pack and CalibratorsOrtho-Clinical Diagnostics · 2002 · cites it directly1descendant
K032296Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsOrtho-Clinical Diagnostics, Inc. · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K972133	Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070)…	Johnson & Johnson Clinical Diagnostics, Inc.	1997	—
+1	K022901	Vitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators	Ortho-Clinical Diagnostics	2002	—
+2	K032296	Vitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators	Ortho-Clinical Diagnostics, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0

FIG. 1 — Lineage of K972133, 1997–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in JLS? 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

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K022901	Vitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators	Ortho-Clinical Diagnostics	2002	1

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, K022901 (Ortho-Clinical Diagnostics, 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JLS devices

JLS Radioimmunoassay, Progesterone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JLS

FDA has decided no JLS device since 2007.

Median 510(k) review, days · JLS

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

Recalls per year · JLS

1in 2022

2007high 3 (2018) · low 0 (2007)2026

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

Adverse event reports per year · JLS

3in 2025

2007high 41 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	1	0
2009	—	0	0
2010	—	1	1
2011	—	0	1
2012	—	0	6
2013	—	0	19
2014	—	0	1
2015	—	0	1
2016	—	0	6
2017	—	0	9
2018	—	3	1
2019	—	0	7
2020	—	0	4
2021	—	1	41
2022	—	1	17
2023	—	0	18
2024	—	0	7
2025	—	0	3
2026	—	0	—

What is it indicated for?

VITROS Progesterone Reagent Pack - For the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) in the diagnosis and treatment of disorders of the ovaries or placenta

VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum or plasma in the diagnosis and treatment of disorders of the ovaries or placenta

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972133 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972133: Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070), Progesterone Calibrators (Gem.C070).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972133

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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