Cleared Traditional

K880266 - MULTI-ENZYME LINEARITY SOLUTION

K880266 is an FDA 510(k) clearance for MULTI-ENZYME LINEARITY SOLUTION, manufactured by Verichem Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K880266 · Verichem Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
27d
Days
Class 1
Risk

K880266 is an FDA 510(k) clearance for the MULTI-ENZYME LINEARITY SOLUTION. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Verichem Laboratories, Inc. (East Providence, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: 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 Verichem Laboratories, Inc. devices

FDA 510(k) Submission Details - K880266

510(k) Number K880266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1988
Decision Date February 18, 1988
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJT Enzyme Controls (assayed And Unassayed)

All 81
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K880266.
CK-MB/LD-1 CONTROL SYSTEM
K894207 · Boehringer Mannheim Corp. · Aug 1989
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · Baxter Healthcare Corp · Aug 1988
QUANTIMETRIX SERUM ENZYME CONTROL
K880701 · Quantimetrix Corp. · Mar 1988
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · Helena Laboratories · Nov 1987
VIRON(TM)
K872646 · bioMerieux, Inc. · Sep 1987
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
K870737 · U. S. Diagnostics, Inc. · Apr 1987