Cleared Traditional

K844679 - DSL PAP RIA -DSL#3100

K844679 is the FDA 510(k) clearance for DSL PAP RIA -DSL#3100 by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K844679 · Diagnostic Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
150d
Days
Class 2
Risk

K844679 is an FDA 510(k) clearance for the DSL PAP RIA -DSL#3100. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 150 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1020 - 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K844679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date April 29, 1985
Days to Decision 150 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
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFH Acid Phosphatase (prostatic), Tartrate Inhibited
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1020
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 - JFH Acid Phosphatase (prostatic), Tartrate Inhibited

All 28
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K844679.
NAPHTHYL PHOSPHATE, ACID PHOSPHATASE
K863832 · Pointe Scientific, Inc., · Dec 1986
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845 · Diagnostic Products Corp. · Sep 1985
TANDEM E PAP
K851950 · Hybritech, Inc. · Jun 1985
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC
K843230 · Ventrex Laboratories, Inc. · Sep 1984
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
K831670 · Ortho Diagnostic Systems, Inc. · Aug 1983
CORDIA PAP
K831105 · Cordis Corp. · May 1983