Cleared Traditional

K852999 - QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT

K852999 is an FDA 510(k) clearance for QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT, manufactured by Kallestad Laboratories, Inc.. The device is a Class 2 Immunology device with product code DEH cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K852999 · Kallestad Laboratories, Inc. · Immunology device
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Oct 1985
Decision
98d
Days
Class 2
Risk

K852999 is an FDA 510(k) clearance for the QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on October 21, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kallestad Laboratories, Inc. devices

FDA 510(k) Submission Details - K852999

510(k) Number K852999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date October 21, 1985
Days to Decision 98 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
7d faster than avg
Panel avg: 105d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEH Device Classification - Class 2, Special Controls

Product Code DEH Lambda, 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 Immunology devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 45
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K852999.
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
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K855007 · Kallestad Laboratories, Inc. · Feb 1986
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K855013 · Kallestad Laboratories, Inc. · Feb 1986
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
K842328 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · Kallestad Laboratories, Inc. · Jul 1984
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
K812662 · Dako Corp. · Sep 1981