Cleared Traditional

K811721 - H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME (FDA 510(k) Clearance)

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

K811721 · Immulok, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1981
Decision
28d
Days
Class 2
Risk

K811721 is an FDA 510(k) clearance for the H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5550 - the FDA pathology 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 Immulok, Inc. devices

Submission Details

510(k) Number K811721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1981
Decision Date July 16, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 77d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 Pathology devices follow this clearance model.

Regulatory Peers - DFH Kappa, Antigen, Antiserum, Control

All 62
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K811721.
Diazyme Human Kappa (k) Free Light Chain Assay
K253358 · Diazyme Laboratories, Inc. · Dec 2025
Optilite® Freelite Mx Kappa Free Kit
K250549 · The Binding Site Group , Ltd. · May 2025
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · Sebia · Feb 2024
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
K231290 · The Binding Site, Ltd. · Jan 2024
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · Sebia · Nov 2022