Cleared Traditional

K822897 - DSL 1700

K822897 is an FDA 510(k) clearance for DSL 1700, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JHW cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K822897 · Diagnostic Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
78d
Days
Class 2
Risk

K822897 is an FDA 510(k) clearance for the DSL 1700. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on December 15, 1982 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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

FDA 510(k) Submission Details - K822897

510(k) Number K822897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1982
Decision Date December 15, 1982
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHW Device Classification - Class 2, Special Controls

Product Code JHW U.v. Method, Cpk Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - JHW U.v. Method, Cpk Isoenzymes

All 25
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K822897.
LABELLING CHANGES TO IMPRES-MB-X
K903508 · Intl. Immunoassay Laboratories, Inc. · Sep 1990
ISOFOR-MM (TM)
K883222 · Intl. Immunoassay Laboratories, Inc. · Sep 1988
IMPRES-MB
K881801 · Intl. Immunoassay Laboratories, Inc. · Jun 1988
CARDIOZYME PLUS CK-MB ITEM #65045
K811573 · Harleco · Jun 1981
CARDIOZYME PLUS CK-MB ITEM #65045 (G)
K811575 · Harleco · Jun 1981
CREATINE KINASE MB ISOENZYME IMMUNO UV
K810861 · The Dow Chemical Co. · Apr 1981