Cleared Traditional

K880700 - ENZYGNOST TAT REAGENTS

K880700 is the FDA 510(k) clearance for ENZYGNOST TAT REAGENTS by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K880700 · Behring Diagnostics, Inc. · Hematology device
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Apr 1988
Decision
65d
Days
Class 2
Risk

K880700 is an FDA 510(k) clearance for the ENZYGNOST(R) TAT REAGENTS. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on April 27, 1988 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - the FDA hematology 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K880700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1988
Decision Date April 27, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 113d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBQ Antithrombin Iii Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
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 Hematology devices follow this clearance model.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 39
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K880700.
ACTICHROME ATIII KIT
K893608 · American Diagnostic Corp. · Jun 1989
TURBOX ANTITHROMBIN III
K884144 · Unipath , Ltd. · Dec 1988
BERICHROM(R) ANTITHROMBIN III
K883662 · Behring Diagnostics, Inc. · Nov 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315 · Baxter Healthcare Corp · Mar 1988
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214 · Instrumentation Laboratory CO · Nov 1986
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · Warner-Lambert Co. · May 1985