510(k) Report

510(k) · Cleared

Cleared

Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I and Midstream II)

K123050510(k) TraditionalCleared Feb 5, 2013130-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

Nantong Biotechnology Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter

Cleared on Feb 5, 2013 as substantially equivalent to K993317 (ACON Laboratories, Inc., 1999) after a 130-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.

Decided
Feb 5, 2013
Review
130 days
Class
Class II
Product code
LCX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K993317 (1999). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2022: 1 descendant clearedK993317 · Acon HCG One Step Pregnancy Test Device (Urine) · ACON Laboratories, Inc. · 1999 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K993317 · Acon HCG One Step Pregnancy Test Device (Urine) · ACON Laboratories, Inc. · 1999 · recalled0
  1. Root · 1 generation backK993317 Acon HCG One Step Pregnancy Test Device (Urine)ACON Laboratories, Inc. · 1999 · Recalled
  2. This deviceK123050 Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette…Nantong Biotechnology Co., Ltd. · 2013
  3. Descendant · cites it directly · 1 of its ownK193132 CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy…Hangzhou Clongene Biotech Co., Ltd. · 2019
  4. Descendant · 2 generations on · 0 of its ownK212447 SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step…Hangzhou Sejoy Electronics & Instruments Co., Ltd. · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip…Hangzhou Clongene Biotech Co., Ltd. · 2019 · cites it directly1descendant
  • K212447SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette…Hangzhou Sejoy Electronics & Instruments Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993317Acon HCG One Step Pregnancy Test Device (Urine)ACON Laboratories, Inc.19992
0 (this device)K123050Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I…Nantong Biotechnology Co., Ltd.2013—
+1K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test…Hangzhou Clongene Biotech Co., Ltd.2019—
+2K212447SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test…Hangzhou Sejoy Electronics & Instruments Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202210
FIG. 1 — Lineage of K123050, 1999–2022Source: 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), 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K993317Acon HCG One Step Pregnancy Test Device (Urine)
Summary page 1
…I LOX 21 CFR, 862.1155 1 JHI 121 OFR 862.1155 5. Predicate Devices: 1. K993317 Acon Laboratories, Inc, ACON® One Step Pregnancy Test Device, 6. Intended Use: EGENS One Step HOG Urine Pregnancy T…
ACON Laboratories, Inc.19992

Also cleared against K993317: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip…Hangzhou Clongene Biotech Co., Ltd.20191

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?

  • Its one ancestor has a recall.
  • Of its descendants, K193132 (Hangzhou Clongene Biotech Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K993317.

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. 2013, this device’s year, is highlighted.

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?

EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users. EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early…

Read the full statement (155 words)

EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Midstream 1)is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Midstream 11) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by home users.

Indications for use as stated in the FDA summary.

Also cleared against K993317

1 other device cites the same predicate.

  • K102760Atlas Home Pregnancy Test (Midstream Format) Model 70172001Atlas Medical · 2011

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/K123050 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123050: Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I and Midstream II).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123050

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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