Cleared Traditional

CALIBRATION REFERENCE I & II (K855035) - FDA 510(k) Clearance

Class I Chemistry device.

K855035 · Integrated Medical Systems Int'L., Inc. · Chemistry device
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Mar 1986
Decision
90d
Days
Class 1
Risk

K855035 is an FDA 510(k) clearance for the CALIBRATION REFERENCE I & II. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Integrated Medical Systems Int'L., Inc. (Mc Allen, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Integrated Medical Systems Int'L., Inc. devices

Submission Details

510(k) Number K855035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date March 17, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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 169
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K855035.
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · Bio-Rad · Aug 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
PRECINORM IM AND PRECIPATH IM
K860970 · Boehringer Mannheim Corp. · Apr 1986
PRECINORM H & PRECIPATH H
K850017 · Boehringer Mannheim Corp. · Mar 1985
PARAGON TRICHECK ELECTROPHORESIS CONTROL
K844996 · Beckman Instruments, Inc. · Feb 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
K844125 · Bio-Rad · Jan 1985