Cleared Traditional

K853943 - CRITIC C LEVEL I & II

K853943 is the FDA 510(k) clearance for CRITIC C LEVEL I & II by Dimension Diagnostics. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K853943 · Dimension Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
90d
Days
Class 1
Risk

K853943 is an FDA 510(k) clearance for the CRITIC C LEVEL I & II. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Dimension Diagnostics (St. Peters, US). The FDA issued a Cleared decision on December 23, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dimension Diagnostics devices

Submission Details

510(k) Number K853943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date December 23, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · 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 475
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K853943.
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED
K861000 · Ciba Corning Diagnostics Corp. · Apr 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355 · American Dade · Mar 1986
RANGE-CHEK
K854789 · American Monitor Corp. · Jan 1986
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL
K853931 · Quantimetrix Corp. · Oct 1985
DC LIQUITROL LEVEL 1 & 2
K852753 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1985
DC-LIP, CATALOGUE NUMBER SE-020
K852594 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985