DSL Estrone (DSL 8700)

K935013510(k) TraditionalCleared Jun 16, 1994239-day reviewClass I21 CFR 862.1280Recalls 4

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

Diagnostic Systems Laboratories, Inc. · CGF Radioimmunoassay, Estrone

Cleared on Jun 16, 1994 after a 239-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 4 times.

Decided: Jun 16, 1994
Review: 239 days
Class: Class I
Product code: CGF
Recalls: 4
Predicates: 0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K935013Source: FDA 510(k) database · How lineage is built

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.

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Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 15, 2025	Class II	Z-1369-2026	Equipment maintenance	The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
Jun 12, 2025	Class II	Z-2336-2025	Nonconforming Material/Component	Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some…
Jun 12, 2025	Class II	Z-2152-2025	Nonconforming Material/Component	A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased…
Apr 22, 2010	Not classified	Z-1685-2011	Other	Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A, 100205RA, and 100226A have now expired and should not be…

No ancestor or descendant has a Class I recall.

How does its category compare?

All CGF devices

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

FDA decisions per year · CGF

FDA has decided no CGF device since 2007.

Median 510(k) review, days · CGF

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

Recalls per year · CGF

1in 2010

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · CGF

No MAUDE report names CGF since 2007.

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	—	0	0
2010	—	1	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K935013 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935013: DSL Estrone (DSL 8700).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935013

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026