510(k) Report

510(k) · Cleared

Cleared

Azog, Inc. HCG One-Step Urine Home Pregnancy Test (Dip Stick, Cassette and Midstream)

K041748510(k) AbbreviatedCleared Aug 9, 200441-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

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

Cleared on Aug 9, 2004 as substantially equivalent to K022680 (Azog, Inc., 2002) and 1 other predicate after a 41-day review. Its family tree reaches back 1 generation to 2002.

Decided
Aug 9, 2004
Review
41 days
Class
Class II
Product code
LCX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K022680 (2002). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK022680 · Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick) · Azog, Inc. · 20022000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K022680 · Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick) · Azog, Inc. · 20020
  1. Root · 1 generation backK022680 Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick)Azog, Inc. · 2002
  2. This deviceK041748 Azog, Inc. HCG One-Step Urine Home Pregnancy Test (Dip Stick…Azog, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022680Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick)Azog, Inc.2002—
0 (this device)K041748Azog, Inc. HCG One-Step Urine Home Pregnancy Test (Dip Stick, Cassette and…Azog, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K041748, 2002–2004Source: 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? (2)

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
*K022680Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick)
Summary page 2
…G One-Step Urine Home Pregnancy Test [DipStick, Device (Cassette) and Midstream] SAFETY AND EFFECTIVENESS DATA: Assay Precision/Tolerance (k022680 and k022681) An evaluation of AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick, Cassette and Midstream) was c…
Azog, Inc.2002—
*K022681Azog, Inc. HCG One-Step Urine Pregnancy Test (Device or Cassette)
Summary page 2
…rine Home Pregnancy Test [DipStick, Device (Cassette) and Midstream] SAFETY AND EFFECTIVENESS DATA: Assay Precision/Tolerance (k022680 and k022681) An evaluation of AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick, Cassette and Midstream) was conducted usi…
Azog, Inc.2002—

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?

  • None of the 2 ancestors has a recall.

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?

AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (DipStick, Cassette and Midstream) are intended for the qualitative determination of Human Chrionic Gonadotropin (hCG) in Human Urine. The test is for Over-The-Counter and/or Professional Use. The test is for the early detection of pregnancy.

Indications for use as stated in the FDA summary.

More from Azog, Inc.

3 FDA decisions under this applicant name. See the company

  • K022681Azog, Inc. HCG One-Step Urine Pregnancy Test (Device or Cassette)Azog, Inc. · 2002
  • K022680Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick)Azog, Inc. · 2002

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/K041748 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041748: Azog, Inc. HCG One-Step Urine Home Pregnancy Test (Dip Stick, Cassette and Midstream).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041748

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