Cleared Traditional

K882998 - ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST

K882998 is an FDA 510(k) clearance for ACUTE PHASE C-REACTIVE PROTEIN LATEX AG..., manufactured by Amtec Diagnostics International, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K882998 · Amtec Diagnostics International, Inc. · Immunology device
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Sep 1988
Decision
51d
Days
Class 2
Risk

K882998 is an FDA 510(k) clearance for the ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Amtec Diagnostics International, Inc. (Conroe, US). The FDA issued a Cleared decision on September 7, 1988 after a review of 51 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 Amtec Diagnostics International, Inc. devices

FDA 510(k) Submission Details - K882998

510(k) Number K882998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1988
Decision Date September 07, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 105d · This submission: 51d
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 106
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K882998.
SPQ TM TEST SYSTEM II FOR CRP
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K890423 · Texas Immunology, Inc. · Feb 1989
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
VISION(R) CRP
K875345 · Abbott Laboratories · Mar 1988