Cleared Traditional

K863112 - PROTEINMETER

K863112 is an FDA 510(k) clearance for PROTEINMETER, manufactured by J. D. Assoc.. The device is a Class 2 Chemistry device with product code JGP cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K863112 · J. D. Assoc. · Chemistry device
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Dec 1986
Decision
119d
Days
Class 2
Risk

K863112 is an FDA 510(k) clearance for the PROTEINMETER. Classified as Lowry (colorimetric), Total Protein (product code JGP), Class II - Special Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 10, 1986 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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 J. D. Assoc. devices

FDA 510(k) Submission Details - K863112

510(k) Number K863112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date December 10, 1986
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGP Device Classification - Class 2, Special Controls

Product Code JGP Lowry (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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.