Cleared Special

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW (K990664) - FDA 510(k) Clearance

Class I Microbiology device.

K990664 · Intracel Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
30d
Days
Class 1
Risk

K990664 is an FDA 510(k) clearance for the PRIMA SYSTEM - OLD, BARTELS ELISA - NEW. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Intracel Corp. (Rockville, US). The FDA issued a Cleared decision on March 31, 1999 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intracel Corp. devices

Submission Details

510(k) Number K990664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date March 31, 1999
Days to Decision 30 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LLH Reagents, Clostridium Difficile Toxin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LLH Reagents, Clostridium Difficile Toxin

All 41
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K990664.
SensiTox C. difficile Toxin Test
K193490 · First Light Diagnostics, Inc. · Jul 2021
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · bioMerieux, Inc. · Jun 2008
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · bioMerieux, Inc. · Dec 2007
COLORPAC TOXIN A
K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
CULTURETTE BRAND TOXIN CD TEST
K925329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993