Cleared Special

K990664 - PRIMA SYSTEM - OLD, BARTELS ELISA - NEW

K990664 is an FDA 510(k) clearance for PRIMA SYSTEM - OLD, manufactured by Intracel Corp.. The device is a Class 1 Microbiology device with product code LLH cleared through the Special 510(k) pathway after a 30-day FDA review.

K990664 · Intracel Corp. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K990664

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LLH Device Classification - Class 1, General Controls

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.
C. DIFFICILE TOX A/B II
K003306 · Techlab, Inc. · Nov 2000
PREMIER TOXINS A&B, MODEL 616096
K993914 · Meridian Diagnostics, Inc. · Dec 1999
CDTOX A OIA
K991829 · Biostar, Inc. · Nov 1999
COLORPAC TOXIN A
K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
TOX A/B TEST
K971182 · Techlab, Inc. · Jul 1997
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · Biomerieux Vitek, Inc. · Apr 1997
K990664 · PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
Download PDF FDA Summary Intracel Corp.