Cleared Special

K043095 - ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

K043095 is an FDA 510(k) clearance for ROCHE DIAGNOSTICS ELECSYS AFP CALSET II, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code JIT cleared through the Special 510(k) pathway after a 14-day FDA review.

K043095 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
14d
Days
Class 2
Risk

K043095 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS ELECSYS AFP CALSET II. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K043095

510(k) Number K043095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2004
Decision Date November 23, 2004
Days to Decision 14 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 105d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Immunology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 225
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K043095.
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
K043378 · Drew Scientific , Ltd. · Dec 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
K042838 · Ortho-Clinical Diagnostics, Inc. · Dec 2004
OLYMPUS LACTATE, OSR6193
K042406 · Olympus America, Inc. · Dec 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
K042521 · Ortho-Clinical Diagnostics, Inc. · Nov 2004
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
K042307 · Seradyn, Inc. · Nov 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K042651 · Beckman Coulter, Inc. · Oct 2004
K043095 · ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
Download PDF FDA Summary Roche Diagnostics Cor…