Cleared Traditional

K875345 - VISION CRP

K875345 is an FDA 510(k) clearance for VISION CRP, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K875345 · Abbott Laboratories · Immunology device
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Mar 1988
Decision
82d
Days
Class 2
Risk

K875345 is an FDA 510(k) clearance for the VISION(R) CRP. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 21, 1988 after a review of 82 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K875345

510(k) Number K875345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1987
Decision Date March 21, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 104d · This submission: 82d
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 88
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K875345.
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1988
KALLESTAD QM300 CALIBRATOR C PACK
K880729 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
KALLESTAD QM2/QM300 CONTROL C PACK
K880730 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
MODIFIED CRP LATEX TEST
K880016 · Sclavo, Inc. · Feb 1988
CRP
K873865 · Unipath , Ltd. · Oct 1987
TINA-QUANT [A] CRP
K871895 · Boehringer Mannheim Corp. · Jun 1987