Cleared Traditional

K852385 - HYBRITECH IMMUNOCHEMISTRY ANALYZER

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

K852385 · Hybritech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Hybritech, Inc. devices

Submission Details

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
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 34
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K852385.
SYVA ETS SYSTEM
K863245 · Syva Co. · Mar 1987
OLYMPUS PK300
K864834 · Olympus Corp. · Feb 1987
SYNCHRON CX3
K864236 · Beckman Instruments, Inc. · Dec 1986
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K851542 · Alpkem Corp. · May 1985
COBAS MIRA
K851172 · Roche Diagnostic Systems, Inc. · May 1985
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN
K850999 · Technicon Instruments Corp. · Apr 1985