Cleared Traditional

K970227 - IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER

K970227 is an FDA 510(k) clearance for IMMULITE 2000 AUTOMATED IMMUNOASSAY ANA..., manufactured by Dpc Cirrus. The device is a Class 1 Microbiology device with product code JJE cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K970227 · Dpc Cirrus · Microbiology device
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Apr 1997
Decision
81d
Days
Class 1
Risk

K970227 is an FDA 510(k) clearance for the IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Dpc Cirrus (Randolph, US). The FDA issued a Cleared decision on April 8, 1997 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2160 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dpc Cirrus devices

FDA 510(k) Submission Details - K970227

510(k) Number K970227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1997
Decision Date April 08, 1997
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 102d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 159
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