Cleared Traditional

K982767 - RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR

K982767 is an FDA 510(k) clearance for RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, manufactured by Raichem. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K982767 · Raichem · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
46d
Days
Class 2
Risk

K982767 is an FDA 510(k) clearance for the RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Raichem (San Diego, US). The FDA issued a Cleared decision on September 21, 1998 after a review of 46 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 Raichem devices

FDA 510(k) Submission Details - K982767

510(k) Number K982767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date September 21, 1998
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
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 - JIX Calibrator, Multi-analyte Mixture

All 268
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K982767.
MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
K984425 · Boehringer Mannheim Corp. · Jan 1999
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K984014 · Beckman Coulter, Inc. · Dec 1998
PRECISET SERUM PROTEINS CALIBRATOR
K983469 · Boehringer Mannheim Corp. · Nov 1998
ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44
K982501 · Alko Diagnostic Corp. · Sep 1998
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
K981706 · Abbott Laboratories · Jul 1998
CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO
K981795 · Thermo Bioanalysis Corp. · Jun 1998