Cleared Traditional

K895648 - COATED TUBE HIGH SENSITIVITY TSH 100 UI...

K895648 is the FDA 510(k) clearance for COATED TUBE HIGH SENSITIVITY TSH 100 UI... by Ventrex Laboratories, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K895648 · Ventrex Laboratories, Inc. · Chemistry device
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Jan 1990
Decision
120d
Days
Class 2
Risk

K895648 is an FDA 510(k) clearance for the COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on January 18, 1990 after a review of 120 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.

View all Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K895648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date January 18, 1990
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K895648.
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
K934843 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1994
CHOLESTEROL CALIBRATOR SET
K910962 · Casco Standards · Mar 1991
SECONDARY CALIBRATORS
K904698 · Bionostics, Inc. · Nov 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