510(k) Report

510(k) · Cleared

Cleared

Combigene (TM) Anti-Dna #Kaddz, KADD1

K874873510(k) TraditionalCleared Feb 10, 198872-day reviewClass II21 CFR 866.5100

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

Diagnostic Products Corp. · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Cleared on Feb 10, 1988 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 10, 1988
Review
72 days
Class
Class II
Product code
DHN
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK874873 Combigene (TM) Anti-Dna #Kaddz, KADD1Diagnostic Products Corp. · 1988
  2. Descendant · cites it directly · 1 of its ownK072393 Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model…Phadia US, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK253367 EliA CTD 13 ScreenPhadia AB · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K072393Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01Phadia US, Inc. · 2007 · cites it directly1descendant
  • K253367EliA CTD 13 ScreenPhadia AB · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874873Combigene (TM) Anti-Dna #Kaddz, KADD1Diagnostic Products Corp.1988—
+1K072393Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01Phadia US, Inc.20071
+2K253367EliA CTD 13 ScreenPhadia AB2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
202610
FIG. 1 — Lineage of K874873, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · 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 DHN? 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
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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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072393Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01Phadia US, Inc.20071

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?

  • Of its descendants, K072393 (Phadia US, Inc., 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DHN devices

DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DHN

1in 2022

2007: 12012: 12014: 12015: 22016: 22018: 12022: 1
2007high 2 (2015) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHN

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

Recalls per year · DHN

1in 2011

2008: 22010: 12011: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DHN

No MAUDE report names DHN since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—20
20090—00
20100—10
20110—10
20121—00
20130—00
20141—00
20152—00
20162—00
20170—00
20181—00
20190—00
20200—00
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—

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321 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K874873 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874873: Combigene (TM) Anti-Dna #Kaddz, KADD1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874873

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