Cleared Traditional

K842249 - ACTH NORMAL RANGE

K842249 is the FDA 510(k) clearance for ACTH NORMAL RANGE by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Chemistry device (product code CKG) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K842249 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Aug 1984
Decision
70d
Days
Class 2
Risk

K842249 is an FDA 510(k) clearance for the ACTH NORMAL RANGE. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 70 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K842249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1984
Decision Date August 15, 1984
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 10
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K842249.
INCSTAR ACTH IRMA
K940271 · Incstar Corp. · Aug 1994
MODIFIED DSL-2300 ACTH RIA
K900147 · Diagnostic Systems Laboratories, Inc. · Mar 1990
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741 · Nichols Institute Diagnostics · Aug 1988
DPC ACTH KIT
K840018 · Diagnostic Products Corp. · Mar 1984
ADRENOCOR TICOTROPIC HORMONE RADIOIMM
K833471 · Nichols Institute Diagnostics · Jan 1984
ACTH RIA SYSTEM-DSI 2300
K830893 · Diagnostic Systems Laboratories, Inc. · Apr 1983