Cleared Traditional

K892329 - OSMOMETER STANDARD SOLUTIONS

K892329 is the FDA 510(k) clearance for OSMOMETER STANDARD SOLUTIONS by D.R.G. Scientific Industries. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K892329 · D.R.G. Scientific Industries · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
209d
Days
Class 2
Risk

K892329 is an FDA 510(k) clearance for the OSMOMETER STANDARD SOLUTIONS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by D.R.G. Scientific Industries (East Boston, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 209 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 D.R.G. Scientific Industries devices

Submission Details

510(k) Number K892329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1989
Decision Date October 31, 1989
Days to Decision 209 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 88d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 162
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K892329.
SECONDARY CALIBRATORS
K904698 · Bionostics, Inc. · Nov 1990
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648 · Ventrex Laboratories, Inc. · Jan 1990
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
K895649 · Ventrex Laboratories, Inc. · Jan 1990
CHLORIDE STANDARDS ITEM #SR1041
K891999 · Em Diagnostic Systems, Inc. · Aug 1989
DOCUMENT(TM) URIC ACID LINEARITY TEST SET
K893139 · Casco Standards · Jul 1989
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
K884197 · Casco Standards · Dec 1988