Cleared Traditional

K974306 - SANGUI BIOTECH

K974306 is the FDA 510(k) clearance for SANGUI BIOTECH by Sangui Biotech, Inc.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K974306 · Sangui Biotech, Inc. · Chemistry device
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Dec 1997
Decision
36d
Days
Class 2
Risk

K974306 is an FDA 510(k) clearance for the SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Sangui Biotech, Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 23, 1997 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sangui Biotech, Inc. devices

Submission Details

510(k) Number K974306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date December 23, 1997
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 - CEW Radioimmunoassay, Parathyroid Hormone

All 51
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K974306.
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
K011505 · Diagnostic Products Corp. · Jul 2001
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680 · Roche Diagnostics Corp. · Sep 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · Diagnostic Products Corp. · Jul 1999
ACTIVE INTACT PTH
K973514 · Diagnostic Systems Laboratories, Inc. · Oct 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
K962598 · Nichols Institute Diagnostics · Dec 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
K962033 · Nichols Institute Diagnostics · Sep 1996