Cleared Traditional

K955812 - SYSCON TURMOR MARKER CONTROL

K955812 is an FDA 510(k) clearance for SYSCON TURMOR MARKER CONTROL, manufactured by Scantibodies Laboratory, Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K955812 · Scantibodies Laboratory, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
77d
Days
Class 1
Risk

K955812 is an FDA 510(k) clearance for the SYSCON TURMOR MARKER CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Scantibodies Laboratory, Inc. (Miami, US). The FDA issued a Cleared decision on March 12, 1996 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K955812

510(k) Number K955812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date March 12, 1996
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
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 545
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K955812.
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
K961293 · Consolidated Technologies, Inc. · May 1996
IMMUNOLOGY CONTROL
K960824 · Medical Analysis Systems, Inc. · Apr 1996
LIPID CONTROL
K960862 · Medical Analysis Systems, Inc. · Apr 1996
N/T PROTEIN CONTROL SY/L, M AND H
K955858 · Behring Diagnostics, Inc. · Feb 1996
SYSCON CONTROL ASSAYED & UNASSAYED
K954247 · Scantibodies Laboratory, Inc. · Feb 1996
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
K955252 · Nova Biomedical Corp. · Feb 1996