Cleared Traditional

K855035 - CALIBRATION REFERENCE I & II

K855035 is an FDA 510(k) clearance for CALIBRATION REFERENCE I & II, manufactured by Integrated Medical Systems Int'L., Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K855035

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.

JJY Device Classification - Class 1, General Controls

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 601
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K855035.
PRECINORM IM AND PRECIPATH IM
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BOVINE CHEMISTRY CONTROL I.X AND II.X
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RANGE-CHEK
K854789 · American Monitor Corp. · Jan 1986
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