510(k) · Cleared
ClearedAnthos Phacts Version Microplate Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Columbia Bioscience, Inc. · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Cleared on Nov 5, 1996 as substantially equivalent to K894270 (Denley Instruments, Inc., 1989) and 2 other predicates after a 158-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Nov 5, 1996
- Review
- 158 days
- Class
- Class I
- Product code
- JJQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K894270 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK894270 Denley Anthos 2001 ReaderDenley Instruments, Inc. · 1989
- This deviceK962113 Anthos Phacts Version Microplate ReaderColumbia Bioscience, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894270 | Denley Anthos 2001 Reader | Denley Instruments, Inc. | 1989 | — |
| 0 (this device) | K962113 | Anthos Phacts Version Microplate Reader | Columbia Bioscience, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 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 JJQ? 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? (3)
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 |
|---|---|---|---|
| * | K894270 | Denley Anthos 2001 ReaderSummary page 2…0) 995-0508 Name of the Device Anthos PhACTS Version Microplate Reader Common or Usual Name Microplate reader Predicate Devices (1) Anthos 2001 Microplate Reader (K894270); (2) Anthos ht2 Microplate Reader (K931907); (3) Anthos 2010 Microplate Reader (K955077); Intended Use The Anthos PhACTS 2010… | 1989 |
| * | K931907 | Anthos HT Readers, Including the Anthos HT II&IiiSummary page 2…S Version Microplate Reader Common or Usual Name Microplate reader Predicate Devices (1) Anthos 2001 Microplate Reader (K894270); (2) Anthos ht2 Microplate Reader (K931907); (3) Anthos 2010 Microplate Reader (K955077); Intended Use The Anthos PhACTS 2010 Microplate Reader is intended to be used as a… | 1993 |
| * | K955077 | Anthos 2010 ReaderSummary page 2…Name Microplate reader Predicate Devices (1) Anthos 2001 Microplate Reader (K894270); (2) Anthos ht2 Microplate Reader (K931907); (3) Anthos 2010 Microplate Reader (K955077); Intended Use The Anthos PhACTS 2010 Microplate Reader is intended to be used as a general purpose microplate photometer for cl… | 1995 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K894270.
How does its category compare?
All JJQ devicesJJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJQ
FDA has decided no JJQ device since 2007.
Median 510(k) review, days · JJQ
Too few JJQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JJQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJQ
20in 2025
MAUDE reports naming product code JJQ, 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 | 1 |
| 2008 | 0 | — | 2 | 4 |
| 2009 | 0 | — | 1 | 10 |
| 2010 | 0 | — | 0 | 46 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 63 |
| 2014 | 0 | — | 0 | 69 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 1 | 22 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 20 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Anthos PhACTS 2010 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
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/K962113 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962113: Anthos Phacts Version Microplate Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962113
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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