510(k) · Cleared
Recalled · 2008Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chugai Pharmaceuticals Co., Ltd. · MDK Dna-Probe, Reagents, Streptococcal
Cleared on Sep 24, 1998 after a 293-day review. The FDA summary names no predicate by number. It has been recalled 2 times.
- Decided
- Sep 24, 1998
- Review
- 293 days
- Class
- Class I
- Product code
- MDK
- Recalls
- 2
- Predicates
- 0
The FDA summary names no predicate by number.
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 MDK? 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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 30, 2008 | Not classified | Z-1436-2011 | Process control | This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe… |
| May 2, 2007 | Not classified | Z-0145-2008 | Other | Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MDK devicesMDK Dna-Probe, Reagents, Streptococcal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDK
FDA has decided no MDK device since 2007.
Median 510(k) review, days · MDK
Too few MDK 510(k)s in any year since 2007 to give a median.
Recalls per year · MDK
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MDK
1in 2014
MAUDE reports naming product code MDK, 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 | — | 1 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AccuProbe Group B Streptococcus Culture Identification Test is a rapid DNA probe test which utilizes the technique of nucleic acid hybridization for the identification of Group B Streptococcus isolated from culture.
The new indication for use covered in this 510(k) is for culture identification of Group B Streptococcus from vaginal and/or anorectal swab specimens collected from pregnant women at 35 to 37 weeks gestation, and cultured in Lim broth for 18 to 24 hours.
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/K974572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974572: Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974572
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026