Cleared Traditional

K946050 - LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2

K946050 is an FDA 510(k) clearance for LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL ..., manufactured by Clinical Controls, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K946050 · Clinical Controls, Inc. · Immunology device
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Feb 1995
Decision
60d
Days
Class 2
Risk

K946050 is an FDA 510(k) clearance for the LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology 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.

View all Clinical Controls, Inc. devices

FDA 510(k) Submission Details - K946050

510(k) Number K946050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date February 10, 1995
Days to Decision 60 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 105d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 Immunology devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 100
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K946050.
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212 · Randox Laboratories, Ltd. · Jul 1995
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
K951057 · Medical Analysis Systems, Inc. · Apr 1995
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
K945280 · Dupont Medical Products · Mar 1995
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
K944288 · Hemagen Diagnostics, Inc. · Oct 1994
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · Behring Diagnostics, Inc. · Oct 1994
TINA-QUANT CRP
K930621 · Boehringer Mannheim Corp. · Mar 1993