Cleared Traditional

MACRALP(A) ENZYME IMMUNOASSAY KIT (K971157) - FDA 510(k) Clearance

Class I Chemistry device.

K971157 · Strategic Diagnostics, Inc. · Chemistry device
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Apr 1998
Decision
383d
Days
Class 1
Risk

K971157 is an FDA 510(k) clearance for the MACRALP(A) ENZYME IMMUNOASSAY KIT. Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Strategic Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on April 15, 1998 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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. Elevated predicate reliance profile. 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 Strategic Diagnostics, Inc. devices

Submission Details

510(k) Number K971157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date April 15, 1998
Days to Decision 383 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
295d slower than avg
Panel avg: 88d · This submission: 383d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHO Electrophoretic Separation, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - JHO Electrophoretic Separation, Lipoproteins

All 25
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K971157.
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · Helena Laboratories · Aug 2002
SPIFE 2000/3000 LIPOPROTEIN
K013466 · Helena Laboratories · Dec 2001
SPIFE CHOLESTEROL PROFILE KIT
K000603 · Helena Laboratories · Apr 2000
REP CHOLESTEROL PROFILE KIT
K992971 · Helena Laboratories · Oct 1999
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
K980650 · Helena Laboratories · May 1998
REP 3 QUTO-FLUR CHOLESTEROL-30
K962914 · Helena Laboratories · Jan 1997