510(k) · Cleared

Cleared

Crithidia Lucilliae DS Dna Kit (Diagnostic Use)

K930987510(k) TraditionalCleared Aug 10, 1993166-day reviewClass II21 CFR 866.5100

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

The Binding Site, Ltd. · KTL Anti-Dna Indirect Immunofluorescent Solid Phase

Cleared on Aug 10, 1993 after a 166-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Aug 10, 1993
Review: 166 days
Class: Class II
Product code: KTL
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK930987 Crithidia Lucilliae DS Dna Kit (Diagnostic Use)The Binding Site, Ltd. · 1993
Descendant · cites it directly · 0 of its ownK013432 Igg Anti-Ndna Fluorescent Test System; Model # 3040GImmuno Concepts, Inc. · 2001

Most influential descendants

Showing 1 of 1 · See all

K013432Igg Anti-Ndna Fluorescent Test System; Model # 3040GImmuno Concepts, Inc. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930987	Crithidia Lucilliae DS Dna Kit (Diagnostic Use)	The Binding Site, Ltd.	1993	—
+1	K013432	Igg Anti-Ndna Fluorescent Test System; Model # 3040G	Immuno Concepts, Inc.	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K930987, 1993–2001Source: FDA 510(k) summaries, read by 510(k) Report · 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.

Planning a device in KTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KTL device

#1 K192916 NOVA Lite DAPI dsDNA Crithidia luciliae Kitscore 0.5 · 1 generation · no Class I recall

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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? (1)

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

Number	Device	Applicant	Decided	Descendants
K013432	Igg Anti-Ndna Fluorescent Test System; Model # 3040G	Immuno Concepts, Inc.	2001	0

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, K013432 (Immuno Concepts, Inc., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KTL devices

KTL Anti-Dna Indirect Immunofluorescent Solid Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTL

2in 2023

2007high 2 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTL

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

Recalls per year · KTL

No recall names KTL since 2007.

Adverse event reports per year · KTL

No MAUDE report names KTL since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	2	—	0
2019	0	—	0
2020	1	—	0
2021	0	—	0
2022	0	—	0
2023	2	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K930987 · printed Nov 3, 2026

Cite this page

510(k) Report. “K930987: Crithidia Lucilliae DS Dna Kit (Diagnostic Use).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930987

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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