510(k) · Cleared
ClearedStrep B Carrot Broth Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hardy Diagnostics · PQZ Gbs Culture Media, Selective And Differential
Cleared on May 16, 2017 as substantially equivalent to K871447 (Remel Co., 1987) after an 89-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- May 16, 2017
- Review
- 89 days
- Class
- Class I
- Product code
- PQZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871447 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK871447 Todd Hewitt W/Cna (Lim Broth)Remel Co. · 1987 · Recalled
- This deviceK170481 Strep B Carrot Broth KitHardy Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871447 | Todd Hewitt W/Cna (Lim Broth) | Remel Co. | 1987 | 1 |
| 0 (this device) | K170481 | Strep B Carrot Broth Kit | Hardy Diagnostics | 2017 | — |
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 PQZ? 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 |
|---|---|---|---|
| * | K871447 | Todd Hewitt W/Cna (Lim Broth)Summary page 4…I. DEVICE Name of Device: Strep B Carrot Broth™ Kit Classification Name: Selective Culture Medium Regulatory Class: I Product Code: PQZ III. PREDICATE DEVICE LIM Broth, K871447 IV. DEVICE DESCRIPTION Approximately 10-35% of women are asymptomatic carriers of group B streptococci (GBS) in the genital and… | 1987 |
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 K871447.
How does its category compare?
All PQZ devicesPQZ Gbs Culture Media, Selective And Differential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PQZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PQZ
88in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PQZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PQZ
2in 2018
MAUDE reports naming product code PQZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 88 | 0 | 2 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Strep B Carrot Broth™ Kit is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimens collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of GBS. The medium requires 24 hours of incubation but positive…
Read the full statement (162 words)
Strep B Carrot Broth™ Kit is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimens collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of GBS. The medium requires 24 hours of incubation but positive results can be interpreted and reported as early as 16 hours. Due to the properties of Strep B Carrot Broth™ Kit, non-hemolytic GBS cannot be detected by the medium’s color change and require subculture for identification. Any presumptive negative indicated by lack of color change at the end of the incubation period must be subcultured to a non-selective medium (e.g., Tryptic Soy Agar with 5% Sheep Blood) to confirm absence of GBS. Subculture must also be performed to recover isolates for conducting susceptibility testing as recommended for penicillin-allergic women.
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/K170481 · printed Nov 3, 2026
Cite this page
510(k) Report. “K170481: Strep B Carrot Broth Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K170481
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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