Cleared Traditional

K792405 - ELVI ACID & PROSTATIC PHOSPHATASE

K792405 is an FDA 510(k) clearance for ELVI ACID & PROSTATIC PHOSPHATASE, manufactured by Volu Sol Medical Industries. The device is a Class 2 Chemistry device with product code JFH cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K792405 · Volu Sol Medical Industries · Chemistry device
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Dec 1979
Decision
11d
Days
Class 2
Risk

K792405 is an FDA 510(k) clearance for the ELVI ACID & PROSTATIC PHOSPHATASE. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 7, 1979 after a review of 11 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K792405

510(k) Number K792405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1979
Decision Date December 07, 1979
Days to Decision 11 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
78d faster than avg
Panel avg: 89d · This submission: 11d
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 44
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K792405.
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
K801988 · Nordiclab Intl. · Sep 1980
LEECO P.A.P. QUANT. DIAGNOSTIC KIT
K792652 · Leeco Diagnostics, Inc. · Jan 1980
S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO
K792059 · S.F. Biologicals, Inc. · Dec 1979
PROSTATIC ACID RADIOIMMUNOASSAY TEST
K791497 · Clinical Assays, Inc. · Dec 1979
PAP RIA KIT
K791735 · Nuclear Medical Systems, Inc. · Nov 1979
PAP-CHECK RIA KIT
K792043 · Serono Laboratories, Inc. · Oct 1979
K792405 · ELVI ACID & PROSTATIC PHOSPHATASE
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