Cleared Traditional

SERA FOR ANTINUCLEAR ANTIBODIES (K820945) - FDA 510(k) Clearance

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

K820945 · Centers For Disease Control and Prevention · Microbiology device
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Oct 1982
Decision
203d
Days
Class 2
Risk

K820945 is an FDA 510(k) clearance for the SERA FOR ANTINUCLEAR ANTIBODIES. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Walker, US). The FDA issued a Cleared decision on October 26, 1982 after a review of 203 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5100 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Centers For Disease Control and Prevention devices

Submission Details

510(k) Number K820945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1982
Decision Date October 26, 1982
Days to Decision 203 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 102d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, 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 Microbiology devices follow this clearance model.

Regulatory Peers - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 31
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K820945.
AFT-HEP SYSTEM
K860183 · Behring Diagnostics, Inc. · Feb 1986
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776 · Behring Diagnostics, Inc. · Jun 1984
LAB-TEK ANA TEST KIT
K792184 · Miles Laboratories, Inc. · Nov 1979
TEST SYS. FOR NDNA ANTIBODY DETERM.
K780178 · Zeus Scientific, Inc. · Feb 1978
IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER
K780161 · Zeus Scientific, Inc. · Feb 1978