Cleared Traditional

ESTROCEPT STABILIZED ESTROGEN RECEPTOR (K823186) - FDA 510(k) Clearance

Class I Chemistry device.

K823186 · Brl · Chemistry device
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Jan 1983
Decision
73d
Days
Class 1
Risk

K823186 is an FDA 510(k) clearance for the ESTROCEPT STABILIZED ESTROGEN RECEPTOR. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Brl (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Brl devices

Submission Details

510(k) Number K823186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date January 07, 1983
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 195
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K823186.
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
K855225 · Boehringer Mannheim Corp. · Jan 1986
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079 · Beckman Instruments, Inc. · Apr 1985
PRECISET AMMONIA
K843569 · Boehringer Mannheim Corp. · Sep 1984
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
K820772 · Helena Laboratories · May 1982
HELENA VMA-SMC CONTROL
K811912 · Helena Laboratories · Jul 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
K811832 · Boehringer Mannheim Corp. · Jul 1981