Cleared Traditional

K780068 - ALP REAGENT SET

K780068 is the FDA 510(k) clearance for ALP REAGENT SET by Medical Analysis Systems, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K780068 · Medical Analysis Systems, Inc. · Chemistry device
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Feb 1978
Decision
22d
Days
Class 2
Risk

K780068 is an FDA 510(k) clearance for the ALP REAGENT SET. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Medical Analysis Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 7, 1978 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K780068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1978
Decision Date February 07, 1978
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 83
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K780068.
ALKALINE PHOSPHATASE IN SERUM
K781609 · Fisher Scientific Co., LLC · Oct 1978
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K781472 · Beckman Instruments, Inc. · Sep 1978
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K780095 · Harleco · Feb 1978
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K772032 · Harleco · Nov 1977
ALKALINE PHOSPHATASE TEST
K771695 · Sclavo, Inc. · Oct 1977
MULTISTAT III ALKALINE PHOSPHATASE
K771470 · Instrumentation Laboratory CO · Sep 1977