Cleared Traditional

K864312 - IC MICROASSAY

K864312 is an FDA 510(k) clearance for IC MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 2 Immunology device with product code DAK cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K864312 · Diamedix Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
67d
Days
Class 2
Risk

K864312 is an FDA 510(k) clearance for the IC MICROASSAY. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on January 9, 1987 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K864312

510(k) Number K864312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date January 09, 1987
Days to Decision 67 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
38d faster than avg
Panel avg: 105d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAK Device Classification - Class 2, Special Controls

Product Code DAK Complement C1q, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DAK Complement C1q, Antigen, Antiserum, Control

All 16
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K864312.
IMMUSTRIP HAMA IGG
K972873 · Immunomedics, Inc. · Mar 1998
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968 · Kent Laboratories, Inc. · May 1995
C1 RID KIT
K914388 · The Binding Site, Ltd. · Oct 1991
CORDIA IC
K844294 · Cordis Corp. · Feb 1985
ORTHO* SERUM ELISA TEST SYSTEM
K833636 · Ortho Diagnostic Systems, Inc. · Jun 1984
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949 · Ortho Diagnostic Systems, Inc. · Aug 1982