510(k) Report

510(k) · Cleared

Cleared

Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream Test and Dip/Card Strip

K131236510(k) TraditionalCleared Nov 7, 2013190-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

Ucp Biosciences, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter

Cleared on Nov 7, 2013 as substantially equivalent to K012215 (ACON Laboratories, Inc., 2001) after a 190-day review. Its family tree reaches back 1 generation to 2001.

Decided
Nov 7, 2013
Review
190 days
Class
Class II
Product code
LCX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K012215 (2001). No later device cites it as a predicate yet.

K012215 · Quik-Check Home Pregnancy Test · ACON Laboratories, Inc. · 20012000200520102015
K012215 · Quik-Check Home Pregnancy Test · ACON Laboratories, Inc. · 20010
  1. Root · 1 generation backK012215 Quik-Check Home Pregnancy TestACON Laboratories, Inc. · 2001
  2. This deviceK131236 Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette…Ucp Biosciences, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012215Quik-Check Home Pregnancy TestACON Laboratories, Inc.2001—
0 (this device)K131236Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test…Ucp Biosciences, Inc.2013—
FIG. 1 — Lineage of K131236, 2001–2013Source: 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
*K012215Quik-Check Home Pregnancy Test
Summary page 1
…: LCX, JHI Regulation Section: 21 CFR §862.1155 Panel: Clinical Chemistry (75) Device Classification: 11 Predicate Device: The Quik-Check Home Pregnancy Test Device (k0 12215) Product Description: UCP Home Pregnancy Test and UCP Pregnancy Test is a rapid chromatographic immurioassay for qualitatively…
ACON Laboratories, Inc.2001—

Also cleared against K012215: 2 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?

  • Its one ancestor has no recall.
  • 2 other devices also cite its predicate K012215.

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?

UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites. UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of…

Read the full statement (171 words)

UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

UCP Home Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

UCP Home Pregnancy Midstream Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

UCP Home Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Indications for use as stated in the FDA summary.

Also cleared against K012215

2 other devices cite the same predicate.

  • K210341One Step Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022
  • K032661Acon Quick-Check II Home Pregnancy Test Device (Cassette)ACON Laboratories, Inc. · 2003

More from Ucp Biosciences, Inc.

14 FDA decisions under this applicant name. See the company

  • K152908Ucp Compact Drug TestsUcp Biosciences, Inc. · 2016
  • K151213UCP Drug Test Mini CupsUcp Biosciences, Inc. · 2015
  • K132812Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc. · 2014
  • K131811Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsUcp Biosciences, Inc. · 2013
  • K130463Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc. · 2013

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/K131236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131236: Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream Test and Dip/Card Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131236

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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