Cleared Traditional

K874115 - NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER...

K874115 is the FDA 510(k) clearance for NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER... by Sigma Diagnostics, Inc.. It is a Class 2 Immunology device (product code LKJ) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K874115 · Sigma Diagnostics, Inc. · Immunology device
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Nov 1987
Decision
26d
Days
Class 2
Risk

K874115 is an FDA 510(k) clearance for the NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA). Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 26 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.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K874115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1987
Decision Date November 04, 1987
Days to Decision 26 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: 104d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKJ Antinuclear Antibody, 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 Immunology devices follow this clearance model.

Regulatory Peers - LKJ Antinuclear Antibody, Antigen, Control

All 26
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K874115.
SERATEST ENA [SCL-70] KIT
K894411 · Hemagen Diagnostics, Inc. · Aug 1989
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · Immco Diagnostics, Inc. · Oct 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · Immco Diagnostics, Inc. · Oct 1988
KALLESTAD SM/RNP TEST REAGENT
K862313 · Kallestad Laboratories, Inc. · Aug 1986