Cleared Traditional

K921302 - VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

K921302 is an FDA 510(k) clearance for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM, manufactured by Vitek Systems, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K921302 · Vitek Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
131d
Days
Class 2
Risk

K921302 is an FDA 510(k) clearance for the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 28, 1992 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 Vitek Systems, Inc. devices

FDA 510(k) Submission Details - K921302

510(k) Number K921302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date July 28, 1992
Days to Decision 131 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 88d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 289
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K921302.
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
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DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
SINGLE-STEP PREGNANCY, HCG TEST
K922290 · American Medical Products, Inc. · Jul 1992
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505 · Eastman Kodak Company · Mar 1992
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT
K920253 · Medix Biotech, Inc. · Feb 1992