Cleared Traditional

K875285 - MULTI-CHEMISTRY LINEARITY STANDARD

K875285 is an FDA 510(k) clearance for MULTI-CHEMISTRY LINEARITY STANDARD, manufactured by Verichem Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K875285 · Verichem Laboratories, Inc. · Chemistry device
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Sep 1988
Decision
248d
Days
Class 2
Risk

K875285 is an FDA 510(k) clearance for the MULTI-CHEMISTRY LINEARITY STANDARD. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Verichem Laboratories, Inc. (East Providence, US). The FDA issued a Cleared decision on September 2, 1988 after a review of 248 days - an extended review 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: 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.

View all Verichem Laboratories, Inc. devices

FDA 510(k) Submission Details - K875285

510(k) Number K875285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date September 02, 1988
Days to Decision 248 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 88d · This submission: 248d
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 270
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K875285.
SODIUM AND POTASSIUM STANDARD
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QM300 CALIBRATOR B PACK
K875282 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1988