Cleared Traditional

K823186 - ESTROCEPT STABILIZED ESTROGEN RECEPTOR

K823186 is an FDA 510(k) clearance for ESTROCEPT STABILIZED ESTROGEN RECEPTOR, manufactured by Brl. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

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

FDA 510(k) Submission Details - K823186

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.

JJX Device Classification - Class 1, General Controls

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 467
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K823186.
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527 · Quantimetrix Corp. · Jul 1983
PHADEBAS HUMYLASE CONTROL(H)
K823421 · Pharmacia, Inc. · Apr 1983
DAC-CEL DIAGNATAL HCG STANDARDS RD49
K830204 · Wellcome Diagnostics · Feb 1983
BIO INTERFERENCE BLANKING MATERIAL
K823687 · American Monitor Corp. · Jan 1983
HUMAN PLASMA CONTROL FOR CEA-ROCHE
K822219 · Hoffmann-La Roche, Inc. · Dec 1982
PHADEBASE HUMYLASE CONTROL
K822938 · Pharmacia, Inc. · Nov 1982