Cleared Traditional

K971157 - MACRALP(A) ENZYME IMMUNOASSAY KIT

K971157 is an FDA 510(k) clearance for MACRALP(A) ENZYME IMMUNOASSAY KIT, manufactured by Strategic Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JHO cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K971157 · Strategic Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K971157

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
295d slower than avg
Panel avg: 88d · This submission: 383d
Pathway characteristics
Predicate-based equivalence.

JHO Device Classification - Class 1, General Controls

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 24
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K971157.
REP CHOLESTEROL PROFILE KIT
K992971 · Helena Laboratories · Oct 1999
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207
K974854 · Morax · Oct 1998
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
K980650 · Helena Laboratories · May 1998
REP 3 QUTO-FLUR CHOLESTEROL-30
K962914 · Helena Laboratories · Jan 1997
REP FLUR CHOLESTEROL-60 KIT
K964471 · Helena Laboratories · Dec 1996
RAPID ELECTROPHORESIS ANALYZER
K960571 · Helena Laboratories · Oct 1996