510(k) Report

510(k) · Cleared

Cleared

Unimark Midstream Pregnancy Test Stick

K960174510(k) TraditionalCleared Apr 1, 199676-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

Biotech Atlantic, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter

Cleared on Apr 1, 1996 as substantially equivalent to K941090 (Biotech Atlantic, Inc., 1994) after a 76-day review. Its family tree reaches back 1 generation to 1994. 16 later devices descend from it.

Decided
Apr 1, 1996
Review
76 days
Class
Class II
Product code
LCX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K941090 (1994). 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 clearedK941090 · Unistep HCG Pregnancy Test Strip · Biotech Atlantic, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 9 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant K941090 · Unistep HCG Pregnancy Test Strip · Biotech Atlantic, Inc. · 19940+5
  1. Root · 1 generation backK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
  2. This deviceK960174 Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996
  3. Descendant · cites it directly · 15 of its ownK032992 Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
  4. Descendant · 2 generations on · 14 of its ownK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
  5. Descendant · 3 generations on · 2 of its ownK173229 Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018
  6. Descendant · 4 generations on · 1 of its ownK222305 MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022
  7. 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
  • K032992Unimark Home Pregnancy Test DeviceBiotech Atlantic, 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
−1K941090Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc.1994—
0 (this device)K960174Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc.1996—
+1K032992Unimark Home Pregnancy Test DeviceBiotech Atlantic, 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 K960174, 1994–2025Source: 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
*K941090Unistep HCG Pregnancy Test Strip
Summary page 1
…Information Respecting Safety and Effectiveness A. Legally Marketed Device Biotech Atlantic claims substantial equivalence to the UniStep™ HCG Pregnancy Test Device (K941090) currently in commercial distribution (outside the U.S.) by Biotech Atlantic, Inc. Device Description The UniMark™ Midstream Pr…
Biotech Atlantic, Inc.1994—

Also cleared against K941090: 2 other devices →

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
K032992Unimark Home Pregnancy Test DeviceBiotech Atlantic, 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?

  • Its one ancestor has no recall.
  • Of its descendants, K032992 (Biotech Atlantic, Inc., 2003) has gone furthest, with 15 descendants of its own.
  • 2 other devices also cite its predicate K941090.

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?

The UniMark™ Midstream Pregnancy Test Stick is intended for the qualitative measurement of human chorionic gonadotropin (hCG) in urine as a home use screening test for pregnancy.

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

Also cleared against K941090

2 other devices cite the same predicate.

  • K032992Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
  • K013194Unimark HCG Combo Pregnancy TestBiotech Atlantic, Inc. · 2001

More from Biotech Atlantic, Inc.

4 FDA decisions under this applicant name. See the company

  • K032992Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
  • K013194Unimark HCG Combo Pregnancy TestBiotech Atlantic, Inc. · 2001
  • K941090Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994

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/K960174 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960174: Unimark Midstream Pregnancy Test Stick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960174

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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