Cleared Traditional

K902321 - HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)

K902321 is an FDA 510(k) clearance for HI CHEM ENZYME LINEARITY STANDARDS (PRO..., manufactured by Hichem Diagnostics. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K902321 · Hichem Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
36d
Days
Class 1
Risk

K902321 is an FDA 510(k) clearance for the HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235). Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on June 28, 1990 after a review of 36 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 Hichem Diagnostics devices

FDA 510(k) Submission Details - K902321

510(k) Number K902321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1990
Decision Date June 28, 1990
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
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 80
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K902321.
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
K925151 · Bio-Rad · Dec 1992
CK-MB IMMUNOASSAY CONTROL
K905623 · Seradyn, Inc. · Feb 1991
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430 · Bio-Rad · Aug 1990
CLP CK/LD ISOENZYME/IMMUNO CONTROL
K896465 · Creative Laboratory Products, Inc. · Mar 1990
CLP CK/LD ISOENZYME CONTROL
K894554 · Creative Laboratory Products, Inc. · Oct 1989
CK-MB/LD-1 CONTROL SYSTEM
K894207 · Boehringer Mannheim Corp. · Aug 1989