Cleared Traditional

K882258 - DC-LIQUICAL CATALOGUE #SE-030

K882258 is an FDA 510(k) clearance for DC-LIQUICAL CATALOGUE #SE-030, manufactured by Diagnostic Chemicals, Ltd. (Usa). The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K882258 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Aug 1988
Decision
91d
Days
Class 2
Risk

K882258 is an FDA 510(k) clearance for the DC-LIQUICAL CATALOGUE #SE-030. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on August 30, 1988 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K882258

510(k) Number K882258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date August 30, 1988
Days to Decision 91 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
2d slower than avg
Panel avg: 89d · This submission: 91d
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 301
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K882258.
UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS
K884693 · Biomedical Research & Development Laboratories, Inc. · Dec 1988
CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM
K884227 · A-Kem, Inc. · Dec 1988
MULTI-CHEMISTRY LINEARITY STANDARD
K875285 · Verichem Laboratories, Inc. · Sep 1988
TOTAL PROTEIN/ALBUMIN STANDARD
K882116 · Verichem Laboratories, Inc. · Jun 1988
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258 · Baxter Healthcare Corp · May 1988
QM300 CALIBRATOR B PACK
K875282 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1988
K882258 · DC-LIQUICAL CATALOGUE #SE-030
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