Cleared Special

K981455 - THIRD GENERATION PSA CONTROL MODULE

K981455 is an FDA 510(k) clearance for THIRD GENERATION PSA CONTROL MODULE, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code JJY cleared through the Special 510(k) pathway after a 20-day FDA review.

K981455 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
20d
Days
Class 1
Risk

K981455 is an FDA 510(k) clearance for the THIRD GENERATION PSA CONTROL MODULE. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 13, 1998 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K981455

510(k) Number K981455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1998
Decision Date May 13, 1998
Days to Decision 20 days
Submission Type Special
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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 590
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K981455.
CHEM-CHEX STAT (NEW)
K982290 · Streck Laboratories, Inc. · Jul 1998
VIGIL PROTEIN CONTROL
K982224 · Beckman Coulter, Inc. · Jul 1998
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
K981401 · Boehringer Mannheim Corp. · May 1998
LYPHOCHEK IMMUNOASSAY PLUS CONTROL
K981532 · Bio-Rad · May 1998
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
K981474 · Spectral Diagnostics, Inc. · May 1998
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
K981339 · Consolidated Technologies, Inc. · Apr 1998