510(k) · Cleared

Cleared

Elecsys Prolactin Assay

K964748510(k) TraditionalCleared Jan 21, 199756-day reviewClass I21 CFR 862.1625

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

Boehringer Mannheim Corp. · CFT Radioimmunoassay, Prolactin (Lactogen)

Cleared on Jan 21, 1997 as substantially equivalent to K900695 (Boehringer Mannheim Corp., 1990) after a 56-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.

Decided: Jan 21, 1997
Review: 56 days
Class: Class I
Product code: CFT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K900695 (1990). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK900695 Enzymun Test (R) ProlactinBoehringer Mannheim Corp. · 1990
This deviceK964748 Elecsys Prolactin AssayBoehringer Mannheim Corp. · 1997
Descendant · cites it directly · 1 of its ownK052982 Roche Diagnostics Cobas Elecsys Prolactin II CalsetRoche Diagnostics · 2005
Descendant · 2 generations on · 0 of its ownK163544 Lumipulse G ProlactinFujirebio Diagnostics,Inc. · 2017

Most influential descendants

Showing 2 of 2 · See all

K052982Roche Diagnostics Cobas Elecsys Prolactin II CalsetRoche Diagnostics · 2005 · cites it directly1descendant
K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc. · 2017 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900695	Enzymun Test (R) Prolactin	Boehringer Mannheim Corp.	1990	—
0 (this device)	K964748	Elecsys Prolactin Assay	Boehringer Mannheim Corp.	1997	—
+1	K052982	Roche Diagnostics Cobas Elecsys Prolactin II Calset	Roche Diagnostics	2005	—
+2	K163544	Lumipulse G Prolactin	Fujirebio Diagnostics,Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2017	1	0

FIG. 1 — Lineage of K964748, 1990–2017Source: 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 CFT? 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
*	K900695	Enzymun Test (R) Prolactin Summary page 1 …e assay for the determination of prolactin. Classification name: System, Test, Prolactin 3. We claim substantial equivalence to the Enzymun® Prolactin Assay Predicate (K900695). device 4. Sandwich principle. Total duration of assay: 18 minutes (37 °C). Device «1st incubation (9 min.): 10uL of sample,…	Boehringer Mannheim Corp.	1990	—

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
K052982	Roche Diagnostics Cobas Elecsys Prolactin II Calset	Roche Diagnostics	2005	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?

Its one ancestor has no recall.
Of its descendants, K052982 (Roche Diagnostics, 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All CFT devices

CFT Radioimmunoassay, Prolactin (Lactogen): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFT

FDA has decided no CFT device since 2007.

Median 510(k) review, days · CFT

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

Recalls per year · CFT

1in 2018

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CFT

23in 2025

2007high 29 (2022) · low 0 (2007)2025

MAUDE reports naming product code CFT, 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	—	0	0
2009	—	1	2
2010	—	0	1
2011	—	0	4
2012	—	0	4
2013	—	0	0
2014	—	0	1
2015	—	0	0
2016	—	0	6
2017	—	0	18
2018	—	1	27
2019	—	0	12
2020	—	0	20
2021	—	0	23
2022	—	0	29
2023	—	0	27
2024	—	0	25
2025	—	0	23
2026	—	0	—

What is it indicated for?

Immunoassay for the in vitro quantitative determination of human prolactin in human serum and plasma.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964748 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964748: Elecsys Prolactin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964748

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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