Cleared Traditional

K932178 - AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES

K932178 is an FDA 510(k) clearance for AIA-PACK PA CALIBRATION VERIFICATION/LI..., 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 139-day FDA review.

K932178 · Tosoh Medics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
139d
Days
Class 1
Risk

K932178 is an FDA 510(k) clearance for the AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES. 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 September 21, 1993 after a review of 139 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 - K932178

510(k) Number K932178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1993
Decision Date September 21, 1993
Days to Decision 139 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
51d slower than avg
Panel avg: 88d · This submission: 139d
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 446
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K932178.
SPQ MALB CONTROL LEVEL II
K934521 · Incstar Corp. · Nov 1993
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
K932660 · More Diagnostics · Oct 1993
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES
K933744 · Sa Scientific, Inc. · Sep 1993
IMMULITE TSH THIRD GENERATION CONTROL
K930007 · Diagnostic Products Corp. · Aug 1993
DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET
K932870 · Casco Standards · Aug 1993
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3
K932658 · More Diagnostics · Jul 1993