Cleared Traditional

K821898 - ORTHO CLASSICAL PATHWAY COMPL. TEST

K821898 is the FDA 510(k) clearance for ORTHO CLASSICAL PATHWAY COMPL. TEST by Ortho Diagnostic Systems, Inc.. It is a Class 2 Immunology device (product code DBA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K821898 · Ortho Diagnostic Systems, Inc. · Immunology device
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Jul 1982
Decision
18d
Days
Class 2
Risk

K821898 is an FDA 510(k) clearance for the ORTHO CLASSICAL PATHWAY COMPL. TEST. Classified as Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (product code DBA), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on July 16, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5250 - 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K821898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date July 16, 1982
Days to Decision 18 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
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBA Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5250
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 - DBA Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control

All 10
Devices cleared under the same product code (DBA) and FDA review panel - the closest regulatory comparables to K821898.
N ANTISERUM TO C1 INHIBITOR
K960257 · Behring Diagnostics, Inc. · Aug 1996
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
K951967 · Kent Laboratories, Inc. · May 1995
COMPLEMENT C1 INACTIVATOR KIT
K915431 · The Binding Site, Ltd. · Jan 1992
ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)
K781017 · Icl Scientific · Aug 1978
LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
K780335 · Hyland Therapeutic Div., Travenol Laboratories · Mar 1978