510(k) · Cleared
Recalled · Class II · 2024Binax Now Streptococcus Pneumoniae Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Binax, Inc. · GTZ Antisera, All Groups, Streptococcus Spp.
Cleared on Nov 30, 2001 as substantially equivalent to K854852 (Wellcome Diagnostics, 1986) after a 116-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 30, 2001
- Review
- 116 days
- Class
- Class I
- Product code
- GTZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854852 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK854852 Wellcogen Bacterial Antigen KitWellcome Diagnostics · 1986
- This deviceK012521 Binax Now Streptococcus Pneumoniae TestBinax, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK191184 ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020
Most influential descendants
Showing 1 of 1 · See all- K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854852 | Wellcogen Bacterial Antigen Kit | Wellcome Diagnostics | 1986 | — |
| 0 (this device) | K012521 | Binax Now Streptococcus Pneumoniae Test | Binax, Inc. | 2001 | — |
| +1 | K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | Ssi Diagnostica A/S | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 GTZ? 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 |
|---|---|---|---|
| * | K854852 | Wellcogen Bacterial Antigen KitSummary page 1…Strep pneumo test Classification Name: Streptococcus spp. serological reagents (per 21 CFR 8660.3740) Predicate Device: Wellcogen Bacterial Antigen Kit} 510 (k) number K854852 Device Description: The Binax NOW® Streptococcus pneumoniae Test is an immunochromatographic membrane assay used to detect pneum… | 1986 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2024 | Class II | Z-3184-2024 | Process control | Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GTZ devicesGTZ Antisera, All Groups, Streptococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GTZ
FDA has decided no GTZ device since 2007.
Median 510(k) review, days · GTZ
Too few GTZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GTZ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GTZ
10in 2025
MAUDE reports naming product code GTZ, 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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Binax NOW® Streptococcus pneumoniae Test is an in vitro rapid immunochromatographic (ICT) assay for the detection of Streptococcus pneumoniae (S. pneumoniae) antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. Tt is intended, in conjunction with culture and other methods, to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.
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/K012521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012521: Binax Now Streptococcus Pneumoniae Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012521
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026