Cleared Traditional

K942458 - PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED

K942458 is an FDA 510(k) clearance for PRECISION-MULTI-SERA - HUMAN - NORMAL A..., manufactured by Randox Laboratories, Ltd.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K942458 · Randox Laboratories, Ltd. · Chemistry device
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Mar 1995
Decision
293d
Days
Class 1
Risk

K942458 is an FDA 510(k) clearance for the PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on March 13, 1995 after a review of 293 days - an extended review 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: 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K942458

510(k) Number K942458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1994
Decision Date March 13, 1995
Days to Decision 293 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 88d · This submission: 293d
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 593
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