Cleared Traditional

K852385 - HYBRITECH IMMUNOCHEMISTRY ANALYZER

K852385 is an FDA 510(k) clearance for HYBRITECH IMMUNOCHEMISTRY ANALYZER, manufactured by Hybritech, Inc.. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K852385 · Hybritech, Inc. · Chemistry device
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Jul 1985
Decision
37d
Days
Class 1
Risk

K852385 is an FDA 510(k) clearance for the HYBRITECH IMMUNOCHEMISTRY ANALYZER. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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.

FDA 510(k) Submission Details - K852385

510(k) Number K852385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1985
Decision Date July 12, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 89d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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 - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 56
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K852385.
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER
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K852385 · HYBRITECH IMMUNOCHEMISTRY ANALYZER
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