510(k) Report

FDA product code · Immunology

Prealbumin, Fitc, Antigen, Antiserum, Control

DDSClass I21 CFR 866.5060510(k) exempt4 decisions since 19860 recalls

FDA lists DDS as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 1986. No recall names this code. The most-cited predicate is K854811, named by 2 later devices.

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

FIG. A — Illustration, immunology panel

Twenty years of DDS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · DDS

FDA has decided no DDS device since 2007.

Median 510(k) review, days · DDS

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

Recalls per year · DDS

No recall names DDS since 2007.

Adverse event reports per year · DDS

No MAUDE report names DDS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DDS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DDS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do DDS devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K854811Ics Pab Prealbumin Reagent Test KitBeckman Instruments, Inc. · 19862cite it

Which DDS devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K972812Raichem Prealbumin SpiaHemagen Diagnostics, Inc. · 19971generation

What has FDA decided in DDS lately?

  • K972812Raichem Prealbumin SpiaHemagen Diagnostics, Inc. · 1997
  • K964781Immage Immunochemistry System Prealbumin (Pab) ReagentBeckman Instruments, Inc. · 1997
  • K934966SPQ Pal Control Level IIIncstar Corp. · 1994
  • K854811Ics Pab Prealbumin Reagent Test KitBeckman Instruments, Inc. · 1986

All 4 DDS decisions →

Related product codes

Other codes under 21 CFR 866.5060.

JZJ Prealbumin, Antigen, Antiserum, Control