Cleared Traditional

K924862 - AIA-PACK HCG CALIBRATION VERIFICATION TEST SET

K924862 is an FDA 510(k) clearance for AIA-PACK HCG CALIBRATION VERIFICATION T..., manufactured by Tosoh Medics, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K924862 · Tosoh Medics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
91d
Days
Class 1
Risk

K924862 is an FDA 510(k) clearance for the AIA-PACK HCG 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. (South San Francisco, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K924862

510(k) Number K924862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date December 28, 1992
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
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 K924862.
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET
K924852 · Tosoh Medics, Inc. · Jan 1993
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET
K924856 · Tosoh Medics, Inc. · Jan 1993
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET
K924853 · Tosoh Medics, Inc. · Dec 1992
AIA-PACK PAP CALIBRATION VERIFICATION TEST SET
K924854 · Tosoh Medics, Inc. · Nov 1992
AIA-PACK T-U CALIBRATION VERIFICATION TEST SET
K924855 · Tosoh Medics, Inc. · Nov 1992
AIA-PACK FSH CALIBRATION VERIFICATION TEST SET
K924863 · Tosoh Medics, Inc. · Nov 1992