Cleared Traditional

K920845 - VIGIL II

K920845 is an FDA 510(k) clearance for VIGIL II, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Microbiology device with product code DCK cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K920845 · Beckman Instruments, Inc. · Microbiology device
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Dec 1992
Decision
286d
Days
Class 2
Risk

K920845 is an FDA 510(k) clearance for the VIGIL II. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 286 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5270 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K920845

510(k) Number K920845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date December 07, 1992
Days to Decision 286 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 102d · This submission: 286d
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 Microbiology devices follow this clearance model.

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

All 87
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K920845.
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
TIA CRP TEST KIT
K914155 · Crestat Diagnostics, Inc. · Jan 1992
HUMAN C-REACTIVE PROTEIN RID KIT
K905633 · The Binding Site, Ltd. · Jul 1991
WAKO(TM) AUTOKIT CRP
K895598 · Wako Chemicals USA, Inc. · Sep 1989