Cleared Traditional

K831036 - ENA TEST KIT SM & RNP AUTO ANTIBODY

K831036 is an FDA 510(k) clearance for ENA TEST KIT SM & RNP AUTO ANTIBODY, manufactured by Calbiochem-Behring Corp.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K831036 · Calbiochem-Behring Corp. · Immunology device
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Apr 1983
Decision
27d
Days
Class 2
Risk

K831036 is an FDA 510(k) clearance for the ENA TEST KIT SM & RNP AUTO ANTIBODY. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1983 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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.

FDA 510(k) Submission Details - K831036

510(k) Number K831036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1983
Decision Date April 27, 1983
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
78d faster than avg
Panel avg: 105d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 181
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K831036.
SERATEST ENA(RNP/SM) DETERMINATION
K844743 · Seragen Diagnostics, Inc. · Feb 1985
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
K843978 · Behring Diagnostics, Inc. · Dec 1984
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K840221 · Zeus Scientific, Inc. · May 1984
NUCLEAR ANTIGENS
K810592 · Alpha Antigens, Inc. · Oct 1981
K831036 · ENA TEST KIT SM & RNP AUTO ANTIBODY
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