Cleared Traditional

K924853 - AIA-PACK BHCG CALIBRATION VERIFICATION ...

K924853 is the FDA 510(k) clearance for AIA-PACK BHCG CALIBRATION VERIFICATION ... by Tosoh Medics, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K924853 · 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

K924853 is an FDA 510(k) clearance for the AIA-PACK BHCG 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

Submission Details

510(k) Number K924853 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.

Device Classification

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 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K924853.
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD
K924493 · Casco Standards · Jan 1993
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 HCG CALIBRATION VERIFICATION TEST SET
K924862 · 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