Cleared Traditional

K791825 - LY-PRO-TROL #ACS-LP101

K791825 is the FDA 510(k) clearance for LY-PRO-TROL #ACS-LP101 by Analytical Control Systems, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K791825 · Analytical Control Systems, Inc. · Chemistry device
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Oct 1979
Decision
14d
Days
Class 1
Risk

K791825 is an FDA 510(k) clearance for the LY-PRO-TROL #ACS-LP101. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Analytical Control Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979 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 Analytical Control Systems, Inc. devices

Submission Details

510(k) Number K791825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1979
Decision Date October 01, 1979
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.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K791825.
CK/LD ISOENZYME CONTROL PROD. #ACS CT101
K800370 · Analytical Control Systems, Inc. · Mar 1980
LIPOTROL
K792024 · Helena Laboratories · Oct 1979
LYOPHILIZED HDL CHOLESTEROL CONTROLS
K792025 · Helena Laboratories · Oct 1979
CONTRO I
K791695 · Hi Chem, Inc. · Sep 1979
CONTRO II
K791696 · Hi Chem, Inc. · Sep 1979
THYROID CONTROL SERA CODE QAS.101
K790840 · Amersham Corp. · Jun 1979