Cleared Traditional

K802997 - HDL-CHOLESTEROL CONTROL SERUM

K802997 is the FDA 510(k) clearance for HDL-CHOLESTEROL CONTROL SERUM by Isolab, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K802997 · Isolab, Inc. · Chemistry device
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Dec 1980
Decision
27d
Days
Class 1
Risk

K802997 is an FDA 510(k) clearance for the HDL-CHOLESTEROL CONTROL SERUM. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Isolab, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 27 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 Isolab, Inc. devices

Submission Details

510(k) Number K802997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1980
Decision Date December 22, 1980
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K802997.
HELENA VMA-SMC CONTROL
K811912 · Helena Laboratories · Jul 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
K811832 · Boehringer Mannheim Corp. · Jul 1981
URINE PREGNANCY TEST STANDARD/CONTR. PK
K811150 · Mallinckrodt Critical Care · May 1981
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068 · Beckman Instruments, Inc. · Oct 1980
CODE QAS.105 PROLACTIN CONTROL SERA
K800708 · Amersham Corp. · Apr 1980
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
K800035 · Miles Laboratories, Inc. · Jan 1980