Cleared Traditional

K880728 - KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK

K880728 is an FDA 510(k) clearance for KALLESTAD QM300 C-REACTIVE PROTEIN ANTI..., manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K880728 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
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Mar 1988
Decision
31d
Days
Class 2
Risk

K880728 is an FDA 510(k) clearance for the KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on March 25, 1988 after a review of 31 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 Kallestad Diag, A Div. of Erbamont, Inc. devices

FDA 510(k) Submission Details - K880728

510(k) Number K880728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1988
Decision Date March 25, 1988
Days to Decision 31 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
74d faster than avg
Panel avg: 105d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

Product Code DCN System, Test, C-reactive Protein
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 - DCN System, Test, C-reactive Protein

All 48
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K880728.
QM300 PCR ANTIBODY PACK
K885001 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1988
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1988
WAKO(TM) CRP
K882374 · Wako Chemicals USA, Inc. · Jul 1988
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
K860679 · Orion Corp. · Aug 1986
CPR SLIDE EIKEN
K854819 · Syn-Kit, Inc. · Feb 1986
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057 · Behring Diagnostics, Inc. · Feb 1986