510(k) · Cleared
ClearedQuickvue Advance PH and Amines GLL Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
Cleared on Apr 29, 2004 as substantially equivalent to K962718 (Litmus Concepts, Inc., 1997) after a 118-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 29, 2004
- Review
- 118 days
- Class
- Class I
- Product code
- CEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962718 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK962718 Femexam TestcardLitmus Concepts, Inc. · 1997
- This deviceK040008 Quickvue Advance PH and Amines GLL TestQuidel Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962718 | Femexam Testcard | Litmus Concepts, Inc. | 1997 | — |
| 0 (this device) | K040008 | Quickvue Advance PH and Amines GLL Test | Quidel Corp. | 2004 | — |
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 CEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K962718 | Femexam TestcardSummary page 2…emonstrated the substantial equivalence of the QuickVue Advance pH and Amines gll test to existing products already marketed, including the FemExam TestCard test [510(k) K962718], also sold under the brand name QuickVue Advance pH and Amines test. They further demonstrated the suitability of the product fo… | 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 K962718.
How does its category compare?
All CEN devicesCEN Dye-Indicator, Ph (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · CEN
Too few CEN 510(k)s in any year since 2007 to give a median.
Recalls per year · CEN
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEN
1in 2018
MAUDE reports naming product code CEN, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The QuickVue Advance pH and Amines gil test contains two calorimetric tests intended for the qualitative detection of elevated vaginal fluid pH (pH > 4.7) and the presence of volatile vaginal fluid amines. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040008: Quickvue Advance PH and Amines GLL Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040008
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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