Cleared Traditional

K864866 - RESUBMISSION OF THE KLEERZIT REAGENT

K864866 is the FDA 510(k) clearance for RESUBMISSION OF THE KLEERZIT REAGENT by Advanced Biomedical Methods, Inc.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K864866 · Advanced Biomedical Methods, Inc. · Chemistry device
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Mar 1987
Decision
95d
Days
Class 2
Risk

K864866 is an FDA 510(k) clearance for the RESUBMISSION OF THE KLEERZIT REAGENT. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Advanced Biomedical Methods, Inc. (Niles, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Biomedical Methods, Inc. devices

Submission Details

510(k) Number K864866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1986
Decision Date March 16, 1987
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 116
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K864866.
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
K883320 · Sherwood Medical Co. · Sep 1988
MONOJECT(R) SNAP-OVER SAFETY CAP
K882614 · Sherwood Medical Co. · Aug 1988
HR VACUTRAC
K881201 · Icu Medical, Inc. · May 1988
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
K864863 · Dynatech Laboratories, Inc. · Jan 1987
MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR
K853152 · Sherwood Medical Co. · Aug 1985
ISOSTAT MICROBIAL TUBE PROCESSING
K840496 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984