Cleared Traditional

K830493 - PROTOPORPHYRIN ZN CONTROL

K830493 is an FDA 510(k) clearance for PROTOPORPHYRIN ZN CONTROL, manufactured by Kaulson Laboratories, Inc.. The device is a Class 1 Toxicology device with product code JJX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K830493 · Kaulson Laboratories, Inc. · Toxicology device
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Apr 1983
Decision
61d
Days
Class 1
Risk

K830493 is an FDA 510(k) clearance for the PROTOPORPHYRIN ZN CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Kaulson Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1983 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology device 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 - K830493

510(k) Number K830493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1983
Decision Date April 18, 1983
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 87d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 490
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K830493.
CHEM TRAK LIQUID BILIRUBIN CONTROL
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BETA SCAN NORMAL CONTROL SOLUTION
K831523 · Orange Medical Instruments, Inc. · Jul 1983
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527 · Quantimetrix Corp. · Jul 1983
PHADEBAS HUMYLASE CONTROL(H)
K823421 · Pharmacia, Inc. · Apr 1983
DAC-CEL DIAGNATAL HCG STANDARDS RD49
K830204 · Wellcome Diagnostics · Feb 1983
ESTROCEPT STABILIZED ESTROGEN RECEPTOR
K823186 · Brl · Jan 1983
K830493 · PROTOPORPHYRIN ZN CONTROL
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