Cleared Traditional

K905215 - IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER

K905215 is an FDA 510(k) clearance for IMMULITE (TM) AUTOMATED IMMUNOASSAY ANA..., manufactured by Cirrus Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K905215 · Cirrus Diagnostics, Inc. · Chemistry device
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Jan 1991
Decision
52d
Days
Class 1
Risk

K905215 is an FDA 510(k) clearance for the IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on January 11, 1991 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - the FDA in vitro diagnostics and chemistry 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 Cirrus Diagnostics, Inc. devices

FDA 510(k) Submission Details - K905215

510(k) Number K905215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date January 11, 1991
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 166
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