Cleared Traditional

K960357 - DSL ACTIVE I-HCG IRMA

K960357 is the FDA 510(k) clearance for DSL ACTIVE I-HCG IRMA by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K960357 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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May 1996
Decision
103d
Days
Class 2
Risk

K960357 is an FDA 510(k) clearance for the DSL ACTIVE I-HCG IRMA. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on May 7, 1996 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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. Standard predicate reliance. 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K960357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date May 07, 1996
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K960357.
ONE-STEP DIPSTICK PREGNANCY TEST
K964536 · Teco Diagnostics · Feb 1997
SAS ONE-STEP PREGNANCY
K964995 · Sa Scientific, Inc. · Jan 1997
DSL ACTIVE I-HCG ELISA
K961911 · Diagnostic Systems Laboratories, Inc. · Jun 1996
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732 · Bio-Rad Laboratories, Inc. · Nov 1995
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273 · Quidel Corp. · Oct 1995
TESTPACK PLUS HCG URINE
K954029 · Abbott Laboratories · Oct 1995