Cleared Traditional

K955266 - ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT

K955266 is an FDA 510(k) clearance for ACCUSTAT HCG SERUM DILUENT REAGENT OR E..., manufactured by Boehringer Mannheim Italia Spa. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K955266 · Boehringer Mannheim Italia Spa · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
106d
Days
Class 2
Risk

K955266 is an FDA 510(k) clearance for the ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Boehringer Mannheim Italia Spa (Simi Valley, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 106 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 Boehringer Mannheim Italia Spa devices

FDA 510(k) Submission Details - K955266

510(k) Number K955266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1995
Decision Date February 29, 1996
Days to Decision 106 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
18d slower than avg
Panel avg: 88d · This submission: 106d
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 279
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K955266.
DSL ACTIVE I-HCG IRMA
K960357 · Diagnostic Systems Laboratories, Inc. · May 1996
BIONIKE A/Q PREGNANCY TEST
K960992 · Bionike Laboratories, Inc. · Apr 1996
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
K955353 · Tcpi, Inc. · Mar 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