510(k) Report

510(k) · Cleared

Cleared

Enzymun Test (R) Prolactin

K900695510(k) TraditionalCleared Mar 30, 199045-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 Mar 30, 1990 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Mar 30, 1990
Review
45 days
Class
Class I
Product code
CFT
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2005: 1 descendant cleared2017: 1 descendant cleared1990200020102020
  1. This deviceK900695 Enzymun Test (R) ProlactinBoehringer Mannheim Corp. · 1990
  2. Descendant · cites it directly · 2 of its ownK964748 Elecsys Prolactin AssayBoehringer Mannheim Corp. · 1997
  3. Descendant · 2 generations on · 1 of its ownK052982 Roche Diagnostics Cobas Elecsys Prolactin II CalsetRoche Diagnostics · 2005
  4. Descendant · 3 generations on · 0 of its ownK163544 Lumipulse G ProlactinFujirebio Diagnostics,Inc. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K964748Elecsys Prolactin AssayBoehringer Mannheim Corp. · 1997 · cites it directly2descendants
  • K052982Roche Diagnostics Cobas Elecsys Prolactin II CalsetRoche Diagnostics · 2005 · 2 generations on1descendant
  • K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K900695Enzymun Test (R) ProlactinBoehringer Mannheim Corp.1990—
+1K964748Elecsys Prolactin AssayBoehringer Mannheim Corp.1997—
+2K052982Roche Diagnostics Cobas Elecsys Prolactin II CalsetRoche Diagnostics2005—
+3K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200510
201710
FIG. 1 — Lineage of K900695, 1990–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K964748Elecsys Prolactin AssayBoehringer Mannheim Corp.19972

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, K964748 (Boehringer Mannheim Corp., 1997) has gone furthest, with 2 descendants 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

2009: 12018: 1
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

2009: 22010: 12011: 42012: 42014: 12016: 62017: 182018: 272019: 122020: 202021: 232022: 292023: 272024: 252025: 23
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—12
20100—01
20110—04
20120—04
20130—00
20140—01
20150—00
20160—06
20170—018
20180—127
20190—012
20200—020
20210—023
20220—029
20230—027
20240—025
20250—023
20260—0—

More from Boehringer Mannheim Corp.

345 FDA decisions under this applicant name. See the company

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K983047Accu-Chek HQ SystemBoehringer Mannheim Corp. · 19991 recall
  • K984419Elecsys Ige CalcheckBoehringer Mannheim Corp. · 1999
  • K984425Modification of Preciset Serum Proteins CalibratorBoehringer Mannheim Corp. · 1999
  • K984372Elecsys Calcheck Troponin TBoehringer Mannheim Corp. · 1998

Recent decisions in CFT

The CFT category page

  • K971921Prolactin (PRL) Hormone Microplate ElisaMonobind · 1997
  • K970281Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsJohnson & Johnson Clinical Diagnostics, Inc. · 19972 recalls
  • K970188Sealite Sciences, Inc. Aqualite ProlactinSealite Sciences, Inc. · 1997
  • K964748Elecsys Prolactin AssayBoehringer Mannheim Corp. · 1997
  • K960561DSL Active Prolactin Elisa Model 10-4500Diagnostic Systems Laboratories, Inc. · 19961 recall

https://510kreport.com/device/K900695 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900695: Enzymun Test (R) Prolactin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900695

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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