Cleared Traditional

K853697 - BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT

K853697 is an FDA 510(k) clearance for BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT, manufactured by Biostar Medical Products, Inc.. The device is a Class 2 Immunology device with product code DAK cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K853697 · Biostar Medical Products, Inc. · Immunology device
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Dec 1985
Decision
103d
Days
Class 2
Risk

K853697 is an FDA 510(k) clearance for the BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by Biostar Medical Products, Inc. (Denver, US). The FDA issued a Cleared decision on December 16, 1985 after a review of 103 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K853697

510(k) Number K853697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date December 16, 1985
Days to Decision 103 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 105d · This submission: 103d
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 27
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K853697.
IC MICROASSAY
K864312 · Diamedix Corp. · Jan 1987
CYTOTECH CIC ENZYME IMMUNOASSAY
K862649 · Cytotech, Inc. · Sep 1986
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
K861499 · Biostar Medical Products, Inc. · Jun 1986
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
K851202 · Gilford · Apr 1985
CORDIA IC
K844294 · Cordis Corp. · Feb 1985
GMP CIQ ELISA TEST KIT
K833275 · Gamma Medical Products, Inc. · Jun 1984
K853697 · BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT
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