Cleared Traditional

K800035 - PENTEX LIPOPROTEIN CHOLESTEROL SOLU.

K800035 is an FDA 510(k) clearance for PENTEX LIPOPROTEIN CHOLESTEROL SOLU., manufactured by Miles Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800035 · Miles Laboratories, Inc. · Chemistry device
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Jan 1980
Decision
14d
Days
Class 1
Risk

K800035 is an FDA 510(k) clearance for the PENTEX LIPOPROTEIN CHOLESTEROL SOLU.. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1980 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K800035

510(k) Number K800035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1980
Decision Date January 21, 1980
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 445
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K800035.
HDL-CHOLESTEROL CONTROL SERUM
K802997 · Isolab, Inc. · Dec 1980
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068 · Beckman Instruments, Inc. · Oct 1980
CODE QAS.105 PROLACTIN CONTROL SERA
K800708 · Amersham Corp. · Apr 1980
CK-MB (CREATINE KINASE-MB) RIA CONTROL
K792524 · Mallinckrodt Critical Care · Jan 1980
SERACON -LO DO26
K791957 · Bhp Diagnostix, Inc. · Oct 1979
BILIRUBIN CALIBRATOR CONTROL
K791141 · Beckman Instruments, Inc. · Aug 1979