Cleared Traditional

K920150 - ENCORE SCL-70

K920150 is an FDA 510(k) clearance for ENCORE SCL-70, manufactured by Clark Laboratories, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K920150 · Clark Laboratories, Inc. · Immunology device
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Mar 1992
Decision
65d
Days
Class 2
Risk

K920150 is an FDA 510(k) clearance for the ENCORE SCL-70. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Clark Laboratories, Inc. (Blairstown, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 65 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 Clark Laboratories, Inc. devices

FDA 510(k) Submission Details - K920150

510(k) Number K920150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1992
Decision Date March 18, 1992
Days to Decision 65 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 105d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K920150.
SYN ELISA DSDNA ANTIBODIES
K921132 · Elias U.S.A., Inc. · Dec 1992
THE THERATEST EL-ANA PROFILES
K914454 · Theratest Laboratories, Inc. · May 1992
AUTOSTAT(TM) ANTI-DSNA
K913342 · Cogent Diagnotics , Ltd. · May 1992
DISTAT ANTI-SCL-70 KIT
K912291 · Shield Diagnostics, Ltd. · Jul 1991
SERATEST ENA [SCL-70] KIT
K894411 · Hemagen Diagnostics, Inc. · Aug 1989
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · Immco Diagnostics, Inc. · Oct 1988