510(k) · Cleared
ClearedGranada Medium
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 Mar 22, 2018 as substantially equivalent to K163042 (bioMerieux, Inc., 2017) after a 90-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Mar 22, 2018
- Review
- 90 days
- Class
- Class I
- Product code
- PQZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881577 (1988). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K163042 | chromID Strepto B agarSummary page 4…m Classification Name: 21 CFR 866.2360 Selective Culture Medium Regulatory Class: I Product Code: PQZ III. PREDICATE DEVICE chromID Strepto B Agar, K163042 IV. DEVICE DESCRIPTION Currently, Group B Streptococci (GBS) remains the primary cause of early-onset neonatal sepsis in the Un… | 2017 |
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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 28.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
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. 2018, 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?
Granada Medium is a selective and differential agar which is intended for the qualitative detection of Group B Streptococcus (GBS) from LIM Broth enrichment cultures of vaginal/rectal swabs from antepartum women following 18-24 hours of incubation. Recovery of orange colored colonies on Granada Medium is a positive result for presence of β-hemolytic GBS. Results can be interpreted after18-24 hours of anaerobic incubation. Due to the properties of Granada…
Read the full statement (137 words)
Granada Medium is a selective and differential agar which is intended for the qualitative detection of Group B Streptococcus (GBS) from LIM Broth enrichment cultures of vaginal/rectal swabs from antepartum women following 18-24 hours of incubation.
Recovery of orange colored colonies on Granada Medium is a positive result for presence of β-hemolytic GBS. Results can be interpreted after18-24 hours of anaerobic incubation. Due to the properties of Granada Medium, white colonies recovered on Granada Medium must undergo additional testing to confirm absence of GBS. Subculture of GBS colonies must be performed for conducting susceptibility testing as recommended for penicillin- allergic women. A lack of growth or the absence of orange colonies on Granada Medium does not preclude the presence of GBS. Granada Medium is not intended to diagnose infection, or to guide or monitor treatment for infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173903 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173903: Granada Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173903
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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