Cleared Traditional

K852260 - QUICK-CHEM CALIBRATION SET

K852260 is the FDA 510(k) clearance for QUICK-CHEM CALIBRATION SET by Seragen Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIW) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K852260 · Seragen Diagnostics, Inc. · Chemistry device
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Jul 1985
Decision
59d
Days
Class 2
Risk

K852260 is an FDA 510(k) clearance for the QUICK-CHEM CALIBRATION SET. Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by Seragen Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 22, 1985 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Seragen Diagnostics, Inc. devices

Submission Details

510(k) Number K852260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1985
Decision Date July 22, 1985
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIW Calibrator, Surrogate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIW Calibrator, Surrogate

All 13
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K852260.
CALIBRATION KIT
K882220 · King Diagnostics, Inc. · Aug 1988
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
K880654 · American Research Products Co. · Jun 1988
UNIMETER CALIBRATION KIT
K880610 · Boehringer Mannheim Corp. · Mar 1988
NEPHELOMETRIC SOLID TURBIDITY STANDARD
K812220 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1981
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1980
CENTRIFICHEM FILTER CALIBRATION SET
K800304 · Union Carbide Corp. · Mar 1980