510(k) · Cleared
ClearedCMV Brite Turbo Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotest Diagnostics Corp. · LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Cleared on Jul 12, 1999 as substantially equivalent to K951550 (Biotest Diagnostics Corp., 1996) after a 60-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 12, 1999
- Review
- 60 days
- Class
- Class II
- Product code
- LIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951550 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK951550 CMV Brite Antigenemia Test KitBiotest Diagnostics Corp. · 1996
- This deviceK991650 CMV Brite Turbo KitBiotest Diagnostics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951550 | CMV Brite Antigenemia Test Kit | Biotest Diagnostics Corp. | 1996 | — |
| 0 (this device) | K991650 | CMV Brite Turbo Kit | Biotest Diagnostics Corp. | 1999 | — |
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 LIN? 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 |
|---|---|---|---|
| * | K951550 | CMV Brite Antigenemia Test KitSummary page 1…any Name and Address: Telephone: FAX: Contact Person: Device Names Proprietary Name: Common Name: Classification Name: Legally Marketed Device CMYV Brite™ Test Kit (K951550) Biotest Diagnostics Corporation 66 Ford Road, Suite 131 Denville, NJ 07834 609-397-8511 609-397-8224 Patricia E. Bonness CMV… | 1996 |
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 no recall.
- 1 other device also cites its predicate K951550.
How does its category compare?
All LIN devicesLIN Antisera, Conjugated Fluorescent, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIN
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · LIN
Too few LIN 510(k)s in any year since 2007 to give a median.
Recalls per year · LIN
No recall names LIN since 2007.
Adverse event reports per year · LIN
No MAUDE report names LIN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 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 | 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 CMV Brite™ Turbo Kit is intended for use in the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence using microscopy in isolated peripheral blood leukocytes obtained from ethylenediaminetreaacetic acid (EDTA) or heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human peripheral blood cells aids in the diagnosis of acute or reactivated CMV infection. This product is not FDA cleared (approved) for use in testing (i.e., screening) of blood or plasma donors.
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/K991650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991650: CMV Brite Turbo Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991650
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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