Cleared Traditional

K895585 - HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)

K895585 is the FDA 510(k) clearance for HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) by Hichem Diagnostics. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K895585 · Hichem Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
59d
Days
Class 2
Risk

K895585 is an FDA 510(k) clearance for the HI CHEM TRIGLYCERIDES CALIBRATOR E (88185). Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on November 13, 1989 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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

Submission Details

510(k) Number K895585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date November 13, 1989
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K895585.
BIOTROL PROTEIN MULTILEVEL STANDARDS
K910721 · Biotrol, USA, Inc. · May 1991
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI
K905820 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1991
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
K905477 · Em Diagnostic Systems, Inc. · Feb 1991
RAICHEM(TM) BILIRUBIN STANDARD
K882726 · Reagents Applications, Inc. · Aug 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693 · Terumo Medical Corp. · Jun 1988
CALCIUM CALIBRATOR
K872051 · Wako Chemicals USA, Inc. · Sep 1987