510(k) Report

510(k) · Cleared

Cleared

Carcinoembryonic Antigen Control (4 Lev

K820298510(k) TraditionalCleared Apr 8, 198263-day reviewClass II21 CFR 866.6010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ventrex Laboratories, Inc. · DHX System, Test, Carcinoembryonic Antigen

Cleared on Apr 8, 1982 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 8, 1982
Review
63 days
Class
Class II
Product code
DHX
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K820298Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DHX device

  1. #1 K223921 Access CEAscore 6.7 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All DHX devices

DHX System, Test, Carcinoembryonic Antigen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DHX

2in 2023

2008: 22009: 12020: 12023: 2
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHX

Too few DHX 510(k)s in any year since 2007 to give a median.

Recalls per year · DHX

1in 2015

2010: 12015: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DHX

19in 2025

2007: 22008: 112009: 202010: 82011: 142012: 142013: 262014: 152015: 332016: 222017: 72018: 202019: 122020: 142021: 112022: 122023: 152024: 152025: 19
2007high 33 (2015) · low 2 (2007)2025

MAUDE reports naming product code DHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20082—011
20091—020
20100—18
20110—014
20120—014
20130—026
20140—015
20150—133
20160—022
20170—07
20180—020
20190—012
20201—014
20210—011
20220—012
20232—015
20240—015
20250—019
20260—0—

More from Ventrex Laboratories, Inc.

82 FDA decisions under this applicant name. See the company

  • K914554Specific Ige Eia-Turbo AssayVentrex Laboratories, Inc. · 1992
  • K913833Ventrex Allergen DiscVentrex Laboratories, Inc. · 1992
  • K913434Ventrex Coated Tube Intact PTHVentrex Laboratories, Inc. · 1991
  • K905612Ventrex Coated Tube Ige RadioimmunoassayVentrex Laboratories, Inc. · 1991
  • K905636Ventrex Coated Tube Ige Enzyme ImmunoassayVentrex Laboratories, Inc. · 1991

Recent decisions in DHX

The DHX category page

  • K223921Access CEABeckman Coulter, Inc. · 2023
  • K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics · 2023
  • K200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc. · 2020
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K080194Vidas Cea (S) AssaybioMerieux, Inc. · 2008

https://510kreport.com/device/K820298 · printed Nov 4, 2026

Cite this page

510(k) Report. “K820298: Carcinoembryonic Antigen Control (4 Lev.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K820298

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026