Cleared Traditional

K811740 - KALLESTAD'S ENDOPLATE FACTOR B TEST

K811740 is the FDA 510(k) clearance for KALLESTAD'S ENDOPLATE FACTOR B TEST by Kallestad Laboratories, Inc.. It is a Class 2 Immunology device (product code JZH) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K811740 · Kallestad Laboratories, Inc. · Immunology device
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Jul 1981
Decision
27d
Days
Class 2
Risk

K811740 is an FDA 510(k) clearance for the KALLESTAD'S ENDOPLATE FACTOR B TEST. Classified as Factor B, Antigen, Antiserum, Control (product code JZH), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5320 - 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 Laboratories, Inc. devices

Submission Details

510(k) Number K811740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1981
Decision Date July 16, 1981
Days to Decision 27 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
77d faster than avg
Panel avg: 104d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZH Factor B, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5320
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 - JZH Factor B, Antigen, Antiserum, Control

Devices cleared under the same product code (JZH) and FDA review panel - the closest regulatory comparables to K811740.
IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT
K964843 · Beckman Instruments, Inc. · Mar 1997
PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
K882623 · Technicon Instruments Corp. · Jul 1988
RADIAL IMMUNO-TEST FOR HUMAN FACTOR B
K831959 · Kent Laboratories, Inc. · Jul 1983
C3PA (GBG) PROPERDIN FACTOR B
K781016 · Icl Scientific · Aug 1978
LAS-R HUMAN C3 PROACTIVATOR TEST
K772084 · Hyland Therapeutic Div., Travenol Laboratories · Jan 1978