Cleared Traditional

K962450 - HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE

K962450 is an FDA 510(k) clearance for HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE, manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K962450 · Hycor Biomedical, Inc. · Immunology device
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Nov 1996
Decision
160d
Days
Class 2
Risk

K962450 is an FDA 510(k) clearance for the HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 160 days - an extended review 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: 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 Hycor Biomedical, Inc. devices

FDA 510(k) Submission Details - K962450

510(k) Number K962450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1996
Decision Date November 25, 1996
Days to Decision 160 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 105d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 79
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K962450.
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
K980337 · Helix Diagnostics, Inc. · May 1998
SERAQUEST ANTI-SSA
K980810 · Quest Intl., Inc. · May 1998
ELIAS ANA-HEP-2
K964385 · Elias U.S.A., Inc. · Mar 1997
ORGENTEC ANTI-RNP/SM ELISA
K962057 · American Laboratory Products Co., Ltd. · Nov 1996
ORGENTEC ANTI-SM ELISA
K962062 · American Laboratory Products Co., Ltd. · Nov 1996
ORGENTEC ABTI-SS-BB(LA) ELISA
K962052 · American Laboratory Products Co., Ltd. · Nov 1996