Cleared Traditional

K960357 - DSL ACTIVE I-HCG IRMA

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

K960357 · Diagnostic Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K960357

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.

JHI Device Classification - Class 2, Special Controls

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 288
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K960357.
SCRIPPS LABORATORIES HCG ONE-STEP
K962906 · Scripps Laboratories, Inc. · Aug 1996
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
K954065 · Biochem Immunosystems (U.S.), Inc. · Jul 1996
DSL ACTIVE I-HCG ELISA
K961911 · Diagnostic Systems Laboratories, Inc. · Jun 1996
BIONIKE A/Q PREGNANCY TEST
K960992 · Bionike Laboratories, Inc. · Apr 1996
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
K955353 · Tcpi, Inc. · Mar 1996
ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT
K955266 · Boehringer Mannheim Italia Spa · Feb 1996