Cleared Traditional

K961998 - QUALITROL SYPHSERO CONTROL SET

K961998 is an FDA 510(k) clearance for QUALITROL SYPHSERO CONTROL SET, manufactured by Consolidated Technologies, Inc.. The device is a Class 2 Microbiology device with product code GMP cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K961998 · Consolidated Technologies, Inc. · Microbiology device
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Aug 1996
Decision
78d
Days
Class 2
Risk

K961998 is an FDA 510(k) clearance for the QUALITROL SYPHSERO CONTROL SET. Classified as Antisera, Control For Nontreponemal Tests (product code GMP), Class II - Special Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on August 8, 1996 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - the FDA microbiology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K961998

510(k) Number K961998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1996
Decision Date August 08, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMP Device Classification - Class 2, Special Controls

Product Code GMP Antisera, Control For Nontreponemal Tests
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GMP Antisera, Control For Nontreponemal Tests

All 8
Devices cleared under the same product code (GMP) and FDA review panel - the closest regulatory comparables to K961998.
ADI SYPHILIS RPR LIQUID CONTROLS
K980638 · Ampcor Diagnostics, Inc. · Jul 1998
RPR LIQUID CONTROLS
K955143 · Remel, L.P. · Jul 1996
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V-TREND RPRL CARD TEST
K875180 · Texas Immunology, Inc. · Feb 1988
VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
K851504 · Ncs Diagnostics, Inc. · Aug 1985
RPR TEST REDITEST
K843741 · Biokit USA, Inc. · Oct 1984
K961998 · QUALITROL SYPHSERO CONTROL SET
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