Cleared Traditional

K872785 - BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTR...

K872785 is the FDA 510(k) clearance for BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTR... by Biotrol, USA, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K872785 · Biotrol, USA, Inc. · Chemistry device
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Aug 1987
Decision
43d
Days
Class 1
Risk

K872785 is an FDA 510(k) clearance for the BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Biotrol, USA, Inc. (Berwyn, US). The FDA issued a Cleared decision on August 26, 1987 after a review of 43 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K872785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date August 26, 1987
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 472
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K872785.
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
K874810 · Biotrol, USA, Inc. · Jan 1988
PRECINORM L
K874230 · Boehringer Mannheim Corp. · Nov 1987
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777 · Biotrol, USA, Inc. · Aug 1987
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
K871977 · American Dade · Jul 1987
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
K872227 · Bio-Rad · Jul 1987
QM2/QM300 CONTROL A PACK
K871342 · Kallestad Diag, A Div. of Erbamont, Inc. · May 1987