510(k) · Cleared

Cleared

Mid Stream Pregnancy Test

K023037510(k) TraditionalCleared Apr 9, 2003209-day reviewClass II21 CFR 862.1155

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

Advanced Diagnostics, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter

Cleared on Apr 9, 2003 as substantially equivalent to K983090 (ACON Laboratories, Inc., 1998) after a 209-day review. Its family tree reaches back 2 generations to 1993.

Decided: Apr 9, 2003
Review: 209 days
Class: Class II
Product code: LCX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K926204 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK926204 Sas One Step PregnancySa Scientific, Inc. · 1993
1 generation backK983090 Acon Midstream Pregnancy TestACON Laboratories, Inc. · 1998
This deviceK023037 Mid Stream Pregnancy TestAdvanced Diagnostics, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K926204	Sas One Step Pregnancy	Sa Scientific, Inc.	1993	—
−1	K983090	Acon Midstream Pregnancy Test	ACON Laboratories, Inc.	1998	—
0 (this device)	K023037	Mid Stream Pregnancy Test	Advanced Diagnostics, Inc.	2003	—

FIG. 1 — Lineage of K023037, 1993–2003Source: 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 LCX? 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 LCX device

#1 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K983090	Acon Midstream Pregnancy Test Summary page 1 …ally marketed devices for the similar intended use. The device used for comparison study is Acon Midstream Pregnancy Test made by Acon Laboratories, Inc. having a 510K #.K983090. Device Description A single swep, visually read, qualitative immuno- chromatographic single use stick test. Intended Use The M…	ACON Laboratories, Inc.	1998	—

Also cleared against K983090: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K983090.

How does its category compare?

All LCX devices

LCX Kit, Test, Pregnancy, Hcg, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCX

5in 2025

2007high 10 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCX

102in 2025

2007high 264 (2022) · low 50 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCX

1in 2025

2007high 8 (2023) · low 0 (2007)2026

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

Adverse event reports per year · LCX

6in 2025

2007high 45 (2008) · low 1 (2017)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	223	0	26
2008	0	—	0	45
2009	2	—	1	8
2010	0	—	2	21
2011	5	234	0	19
2012	1	—	0	3
2013	8	152	0	3
2014	0	—	0	3
2015	2	—	0	2
2016	1	—	0	4
2017	1	—	0	1
2018	4	162	0	2
2019	7	50	0	3
2020	2	—	0	3
2021	2	—	0	4
2022	6	264	0	12
2023	2	—	8	6
2024	10	132	0	3
2025	5	102	1	6
2026	0	—	0	—

What is it indicated for?

The Test is a qualitative immunoassay intended for non professional / Over The Counter Use for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy.

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/K023037 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023037: Mid Stream Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023037

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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