Cleared Traditional

K952251 - IMMULITE HCG HIGH LEVEL CONTROL MODULE

K952251 is an FDA 510(k) clearance for IMMULITE HCG HIGH LEVEL CONTROL MODULE, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K952251

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.

JJX Device Classification - Class 1, General Controls

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 436
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
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K953883 · Bio-Rad Laboratories, Inc. · Nov 1995
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OPUS T4 CONTROLS
K953097 · Behring Diagnostics, Inc. · Aug 1995
DADE STRATUS TROPONIN-I CONTROL
K951888 · Dade Intl., Inc. · Jul 1995
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
K944999 · More Diagnostics · Jun 1995