510(k) · Cleared
Recalled · Class II · 2016Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymed Therapeutics, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Jul 17, 2012 as substantially equivalent to K964461 (Teco Diagnostics, 1997) after a 361-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Jul 17, 2012
- Review
- 361 days
- Class
- Class II
- Product code
- JHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964461 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964461 One -Step Urine/Serum Combo Pregnancy Card TestTeco Diagnostics · 1997
- This deviceK112101 Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsPolymed Therapeutics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964461 | One -Step Urine/Serum Combo Pregnancy Card Test | Teco Diagnostics | 1997 | — |
| 0 (this device) | K112101 | Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests | Polymed Therapeutics, Inc. | 2012 | — |
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 JHI? 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 JHI device
- #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 3 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 |
|---|---|---|---|
| * | K964461 | One -Step Urine/Serum Combo Pregnancy Card TestSummary page 2…yices are: Abbott Architect i2000 instrument k0933 18 Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Test k964461 Performance: The product performance characteristics of Polymed Therapeutics' Fastep TM hCG Pregnancy Serum/Urine Test was evalu… | 1997 |
| † | K093318 | Accelerator Aps | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2016 | Class II | Z-2391-2018 | Process control | Incorrect hCG results |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K964461.
How does its category compare?
All JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JHI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHI
101in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JHI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHI
265in 2025
MAUDE reports naming product code JHI, 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 | 101 | 6 | 245 |
| 2008 | 0 | — | 8 | 29 |
| 2009 | 0 | — | 1 | 106 |
| 2010 | 1 | — | 2 | 143 |
| 2011 | 0 | — | 1 | 138 |
| 2012 | 2 | — | 0 | 219 |
| 2013 | 2 | — | 0 | 185 |
| 2014 | 2 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 134 |
| 2016 | 1 | — | 0 | 143 |
| 2017 | 1 | — | 0 | 113 |
| 2018 | 1 | — | 0 | 132 |
| 2019 | 0 | — | 0 | 571 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 1 | — | 0 | 126 |
| 2023 | 0 | — | 6 | 147 |
| 2024 | 1 | — | 1 | 256 |
| 2025 | 0 | — | 0 | 265 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Polymned Therapeutics' Fastep' hCG Pregnancy Serum/Urine Test is a rapid chromatographic
immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum
or urine specimen to aid in the early detection of pregnancy. For Professional Use Only.
The test kits are for health care professidnals use including professionals at physician's office labs
(POLs) and Point-of-Care site (POC).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112101: Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112101
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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