Cleared Traditional

K952251 - IMMULITE HCG HIGH LEVEL CONTROL MODULE

K952251 is the FDA 510(k) clearance for IMMULITE HCG HIGH LEVEL CONTROL MODULE by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K952251 · Diagnostic Products Corp. · Chemistry device
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Sep 1995
Decision
116d
Days
Class 1
Risk

K952251 is an FDA 510(k) clearance for the IMMULITE HCG HIGH LEVEL CONTROL MODULE. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 116 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K952251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1995
Decision Date September 08, 1995
Days to Decision 116 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 88d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 308
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K952251.
OPUS PROLACTIN CONTROLS
K955468 · Behring Diagnostics, Inc. · Feb 1996
ACCESS LOW LEVEL IGE CONTROLS
K953883 · Bio-Rad Laboratories, Inc. · Nov 1995
OPUS HCG CONTROLS
K954144 · Behring Diagnostics, Inc. · Oct 1995
OPUS T4 CONTROLS
K953097 · Behring Diagnostics, Inc. · Aug 1995
IMMULITE(R) TBG
K950072 · Diagnostic Products Corp. · Apr 1995
REP CHOLESTEROL PROFILE CONTROL
K950590 · Helena Laboratories · Mar 1995