Cleared Traditional

K871755 - PROTEIN STANDARD CALIBRATOR

K871755 is an FDA 510(k) clearance for PROTEIN STANDARD CALIBRATOR, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K871755 · Wako Chemicals USA, Inc. · Chemistry device
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Nov 1987
Decision
202d
Days
Class 2
Risk

K871755 is an FDA 510(k) clearance for the PROTEIN STANDARD CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 202 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K871755

510(k) Number K871755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1987
Decision Date November 23, 1987
Days to Decision 202 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
114d slower than avg
Panel avg: 88d · This submission: 202d
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 272
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K871755.
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K874413 · Seradyn, Inc. · Jan 1988
PARAMAX URINE/CSF CALIBRATOR
K874587 · Baxter Healthcare Corp · Jan 1988
PARAMAX URINE/CSF CALIBRATOR
K872789 · American Dade · Sep 1987
MULTI ANALYTE MIXTURES, CALIBRATORS
K873116 · Biotrol, USA, Inc. · Sep 1987
BIOTROL REFERENCE
K873118 · Biotrol, USA, Inc. · Sep 1987