510(k) Report

510(k) · Cleared

Cleared

Acon One Step Home Pregnancy Test Strip

K993483510(k) TraditionalCleared Jan 20, 200098-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

ACON Laboratories, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter

Cleared on Jan 20, 2000 after a 98-day review. The FDA summary names no predicate by number. 16 later devices descend from it.

Decided
Jan 20, 2000
Review
98 days
Class
Class II
Product code
LCX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2005: 1 descendant cleared2024: 3 descendants cleared2020: 1 descendant cleared2018: 2 descendants cleared2015: 1 descendant cleared2023: 2 descendants cleared2009: 1 descendant cleared2019: 2 descendants cleared2022: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK993483 Acon One Step Home Pregnancy Test StripACON Laboratories, Inc. · 2000
  2. Descendant · cites it directly · 15 of its ownK033041 Acon Quik-Check II Home Pregnancy Test StripACON Laboratories, Inc. · 2003
  3. Descendant · 2 generations on · 14 of its ownK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
  4. Descendant · 3 generations on · 2 of its ownK173229 Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018
  5. Descendant · 4 generations on · 1 of its ownK222305 MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022
  6. Descendant · 3 generations on · 1 of its ownK200133 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test…Safecare Biotech (Hangzhou) Co., Ltd. · 2020

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12009: 12015: 12018: 22019: 22020: 12022: 12023: 22024: 32025: 1
2003high 3 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 16 · See all
  • K033041Acon Quik-Check II Home Pregnancy Test StripACON Laboratories, Inc. · 2003 · cites it directly15descendants
  • K043443One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005 · 2 generations on14descendants
  • K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018 · 3 generations on2descendants
  • K222305MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022 · 4 generations on1descendant
  • K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamSafecare Biotech (Hangzhou) Co., Ltd. · 2020 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993483Acon One Step Home Pregnancy Test StripACON Laboratories, Inc.2000—
+1K033041Acon Quik-Check II Home Pregnancy Test StripACON Laboratories, Inc.2003—
+2K043443One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd.2005—
+3K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd.2018—
+4K222305MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd.2022—
+3K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamSafecare Biotech (Hangzhou) Co., Ltd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200910
201510
201820
201920
202010
202210
202320
202430
202510
FIG. 1 — Lineage of K993483, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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. #1 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K033041Acon Quik-Check II Home Pregnancy Test StripACON Laboratories, Inc.200315

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, K033041 (ACON Laboratories, Inc., 2003) has gone furthest, with 15 descendants of its own.

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

2007: 42009: 22011: 52012: 12013: 82015: 22016: 12017: 12018: 42019: 72020: 22021: 22022: 62023: 22024: 102025: 5
2007high 10 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCX

102in 2025

2007: 223 days median2011: 234 days median2013: 152 days median2018: 162 days median2019: 50 days median2022: 264 days median2024: 132 days median2025: 102 days median
2007high 264 (2022) · low 50 (2019)2026

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

Recalls per year · LCX

1in 2025

2009: 12010: 22023: 82025: 1
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

2007: 262008: 452009: 82010: 212011: 192012: 32013: 32014: 32015: 22016: 42017: 12018: 22019: 32020: 32021: 42022: 122023: 62024: 32025: 6
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074223026
20080—045
20092—18
20100—221
20115234019
20121—03
2013815203
20140—03
20152—02
20161—04
20171—01
2018416202
201975003
20202—03
20212—04
20226264012
20232—86
20241013203
2025510216
20260—0—

What is it indicated for?

ACON™ One Step Home Pregnancy Test Strip is intended for non-professional use for the qualitative identification of human chorionic gonadotropin (hCG) in urine to aid in the determination of pregnancy.

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

More from ACON Laboratories, Inc.

86 FDA decisions under this applicant name. See the company

  • K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc. · 2026
  • K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc. · 2025
  • K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. · 2025
  • K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone…ACON Laboratories, Inc. · 2025
  • K250377Flowflex Plus COVID-19 + Flu A/B Home TestACON Laboratories, Inc. · 2025

Recent decisions in LCX

The LCX category page

  • K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd. · 2025
  • K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd. · 2025
  • K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC · 2025
  • K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test…Nanjing Synthgene Medical Technology Co., Ltd. · 2025
  • K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy…Assure Tech., LLC · 2025

https://510kreport.com/device/K993483 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993483: Acon One Step Home Pregnancy Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993483

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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