510(k) · Cleared
ClearedAtlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlas Link Technology Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Aug 4, 2021 as substantially equivalent to K071930 (Blue Cross Bio-Medical Co., Ltd., 2007) after a 273-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Aug 4, 2021
- Review
- 273 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071930 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK071930 One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG…Blue Cross Bio-Medical Co., Ltd. · 2007
- This deviceK203246 Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG…Atlas Link Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071930 | One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine… | Blue Cross Bio-Medical Co., Ltd. | 2007 | — |
| 0 (this device) | K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine… | Atlas Link Technology Co., Ltd. | 2021 | — |
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 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071930 | One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy…Summary page 4…n chorionic gonadotropin (HCG) test system (21 CFR 862.1155) Product Code: LCX D. Predicate: BLUECROSS BIO-MEDICAL CO., LTD. One Step HCG Urine Pregnancy Test (Strip) (K071930) One Step HCG Urine Pregnancy Test (Cassette) (K071930) One Step HCG Urine Pregnancy Test (Midstream) (K071930). E. Intended Use… | 2007 |
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 K071930.
How does its category compare?
All LCX devicesLCX Kit, Test, Pregnancy, Hcg, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LCX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCX
102in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCX
6in 2025
MAUDE reports naming product code LCX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 223 | 0 | 26 |
| 2008 | 0 | — | 0 | 45 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 0 | — | 2 | 21 |
| 2011 | 5 | 234 | 0 | 19 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 8 | 152 | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 4 | 162 | 0 | 2 |
| 2019 | 7 | 50 | 0 | 3 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 6 | 264 | 0 | 12 |
| 2023 | 2 | — | 8 | 6 |
| 2024 | 10 | 132 | 0 | 3 |
| 2025 | 5 | 102 | 1 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Atlas One Step hCG Urine Pregnancy Test (Strip) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to help in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use. Atlas One Step hCG Urine Pregnancy Test (Cassette) is a visually-read, lateral…
Read the full statement (171 words)
Atlas One Step hCG Urine Pregnancy Test (Strip) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to help in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test (Cassette) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to help in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test (Midstream) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to help in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203246: Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203246
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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