Cleared Traditional

VIGIL II (K920845) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 39
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K920845.
N LATEX CRP MONO REAGENT
K962523 · Behring Diagnostics, Inc. · Jul 1996
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · Behring Diagnostics, Inc. · Oct 1994
TINA-QUANT CRP
K930621 · Boehringer Mannheim Corp. · Mar 1993
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · Technicon Instruments Corp. · May 1989
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1988
VISION(R) CRP
K875345 · Abbott Laboratories · Mar 1988