510(k) · Cleared
ClearedBartels Cinakit CMV Antigenemia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intracel Corp. · GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
Cleared on Dec 14, 1998 as substantially equivalent to K951550 (Biotest Diagnostics Corp., 1996) after a 166-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 14, 1998
- Review
- 166 days
- Class
- Class II
- Product code
- GQH
- 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 deviceK982311 Bartels Cinakit CMV AntigenemiaIntracel Corp. · 1998
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) | K982311 | Bartels Cinakit CMV Antigenemia | Intracel Corp. | 1998 | — |
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 GQH? 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…, product code, 834N, (21 CFR 866.3175). (B) Legally Marketed Device BARTELS CINAKIT CMV Antigenemia claims substantial equivalance to the BIOTEST CMV BRITE TEST Kit (K951550), currently in commercial distribution by BIOTEST Diagnostics, Denville, New Jersey (USA). (C) Device Description BARTELS CINAK… | 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 GQH devicesGQH Antigen, Cf (Including Cf Control), Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GQH
FDA has decided no GQH device since 2007.
Median 510(k) review, days · GQH
Too few GQH 510(k)s in any year since 2007 to give a median.
Recalls per year · GQH
No recall names GQH since 2007.
Adverse event reports per year · GQH
1in 2013
MAUDE reports naming product code GQH, 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 | 1 |
| 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 Bartels CINAkit™ CMV Antigenemia Test is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the rapid direct qualitative detection of CMV pp65 antigen in human blood leukocytes by indirect immunofluorescence (IF). This product is not intended to be used for testing (i.e. screening) 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/K982311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982311: Bartels Cinakit CMV Antigenemia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982311
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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