Cleared Traditional

K844679 - DSL PAP RIA -DSL#3100

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

K844679 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K844679

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.

JFH Device Classification - Class 2, Special Controls

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 34
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