Cleared Traditional

K982608 - SANGUI BIOTECH

K982608 is the FDA 510(k) clearance for SANGUI BIOTECH by Sangui Biotech, Inc.. It is a Class 2 Chemistry device (product code CKG) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K982608 · Sangui Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
23d
Days
Class 2
Risk

K982608 is an FDA 510(k) clearance for the SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Sangui Biotech, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 19, 1998 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1025 - 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 K982608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date August 19, 1998
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CKG Radioimmunoassay, Acth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1025
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 - CKG Radioimmunoassay, Acth

All 11
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K982608.
IDS ACTH II
K223867 · Immunodiagnostic Systems Limited · Aug 2023
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585 · Roche Diagnostics Corp. · May 2006
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · Nichols Institute Diagnostics · Dec 1996
IMMULITE ACTH
K960066 · Diagnostic Products Corp. · Feb 1996
INCSTAR ACTH IRMA
K940271 · Incstar Corp. · Aug 1994
MODIFIED DSL-2300 ACTH RIA
K900147 · Diagnostic Systems Laboratories, Inc. · Mar 1990