Cleared Traditional

K933218 - REFRACTOMETRIC, TOTAL PROTEIN

K933218 is an FDA 510(k) clearance for REFRACTOMETRIC, manufactured by Pyramid Biological Corp.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K933218 · Pyramid Biological Corp. · Chemistry device
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Feb 1994
Decision
231d
Days
Class 1
Risk

K933218 is an FDA 510(k) clearance for the REFRACTOMETRIC, TOTAL PROTEIN. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 231 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Pyramid Biological Corp. devices

FDA 510(k) Submission Details - K933218

510(k) Number K933218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1993
Decision Date February 17, 1994
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 88d · This submission: 231d
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 427
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K933218.
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DOCUMENT(R) ZERO
K940568 · Casco Standards · Apr 1994
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
K934922 · Unipath , Ltd. · Dec 1993
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
K934923 · Unipath , Ltd. · Dec 1993
SPQ MALB CONTROL LEVEL II
K934521 · Incstar Corp. · Nov 1993