510(k) · Cleared
ClearedSofia (R) HCG Fia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Aug 2, 2013 as substantially equivalent to K973858 (Quidel Corp., 1997) after a 100-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Aug 2, 2013
- Review
- 100 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973858 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK973858 Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-ComboQuidel Corp. · 1997
- This deviceK131166 Sofia (R) HCG FiaQuidel Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973858 | Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo | Quidel Corp. | 1997 | — |
| 0 (this device) | K131166 | Sofia (R) HCG Fia | Quidel Corp. | 2013 | — |
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 |
|---|---|---|---|
| * | K973858 | Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-ComboSummary page 2…Predicate Device Featres ofi hCGFIAQuickVue+ One-Step hCG Featres ofi hCGFIACombo test (K973858) Intended Use The Sofia hCG FIA is an The QuickVue+ One-Step hCG… | 1997 |
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.
- 1 other device also cites its predicate K973858.
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. 2013, 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 Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the
qualitative detection of human Chorionic Gonadlotropin (hCG) in urine specimens and is
designed to aid early detection of pregnancy.
The test is intended for prescription use only, including use at point-of-care sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131166: Sofia (R) HCG Fia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131166
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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