510(k) · Cleared
ClearedBionexia HCG Pregnancy Cassette and Dipstick Tests, Model 08-HCG and 02-HCG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Dna Technologies, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Jun 29, 2007 as substantially equivalent to K993203 (ACON Laboratories, Inc., 1999) after an 88-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 29, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993203 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993203 Acon One Step Pregnancy Test Strip (Urine)ACON Laboratories, Inc. · 1999 · Recalled
- This deviceK070921 Bionexia HCG Pregnancy Cassette and Dipstick Tests, Model 08-HCG and…Applied Dna Technologies, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993203 | Acon One Step Pregnancy Test Strip (Urine) | ACON Laboratories, Inc. | 1999 | 3 |
| 0 (this device) | K070921 | Bionexia HCG Pregnancy Cassette and Dipstick Tests, Model 08-HCG and 02-HCG | Applied Dna Technologies, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K993203 | Acon One Step Pregnancy Test Strip (Urine)Summary page 1…s to compare their performance of required studies. 5 10(k) numbers for predicate devices is: ACON One Step Pregnancy Urine Test K 993203 Performance: The product performance characteristics of ADT's BionexiaT M hCG Pregnancy Cassette and Dipsti… | 1999 |
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 a recall.
- 1 other device also cites its predicate K993203.
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. 2007, 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 Applied DNA Technologies Bionexia TM hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine at 20 mIU/mnL and above to help in the early determination of pregnancy.
The test kits are for health care professionals use including professionals at physician's office labs (POLs).
For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070921: Bionexia HCG Pregnancy Cassette and Dipstick Tests, Model 08-HCG and 02-HCG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070921
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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