Cleared Traditional

K924859 - AIA-PACK IGE CALIBRATION VERIFICATION TEST SET

K924859 is an FDA 510(k) clearance for AIA-PACK IGE CALIBRATION VERIFICATION T..., manufactured by Tosoh Medics, Inc.. The device is a Class 1 Immunology device with product code JJX cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K924859 · Tosoh Medics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
228d
Days
Class 1
Risk

K924859 is an FDA 510(k) clearance for the AIA-PACK IGE CALIBRATION VERIFICATION TEST SET. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on May 14, 1993 after a review of 228 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K924859

510(k) Number K924859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date May 14, 1993
Days to Decision 228 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 105d · This submission: 228d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 445
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K924859.
MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM
K932659 · More Diagnostics · Jul 1993
CANNABINOID URINE CONTROLS
K932113 · Diagnostic Reagents, Inc. · Jun 1993
QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)
K931761 · Quidel Corp. · Jun 1993
AUTOSTAT ANTI-DSDNA
K925783 · Cogent Diagnotics , Ltd. · Mar 1993
AIA-PACK AFP CALIBRATION VERIFICATION TEST SET
K924860 · Tosoh Medics, Inc. · Mar 1993
NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K925906 · Analytical Control Systems, Inc. · Feb 1993