Product Code: MJX FDA class 1 21 CFR 862.1660

Kit, Serological, Positive Control

Clinical Chemistry

The Serological Positive Control Kit is a reference reagent used in clinical and diagnostic laboratories as a positive control specimen when performing serological tests, confirming that the assay is functioning correctly and capable of detecting the analyte of interest when it is present. Classified as a Class 1 device under 21 CFR 862.1660 within the Clinical Chemistry specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: MJX
Device Class: FDA class 1
Regulation Number: 862.1660
Medical Specialty: Clinical Chemistry
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K101434	AUDIT MICROCV PROCALCITONIN LINEARITY	Jul 22, 2010	Substantially Equivalent	Aalto Scientific, Ltd.
K030067	VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS	Jan 17, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics
K974262	SYSCOS IDC - G, IDC, BSC, IDC - G	Dec 24, 1997	Substantially Equivalent	Scantibodies Laboratory, Inc.
K972986	ACCURUN 140 RUBELLA IGG POSITIVE CONTROL	Oct 08, 1997	Substantially Equivalent	Boston Biomedica, Inc.
K970100	TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL	Mar 10, 1997	Substantially Equivalent	Simplicity Diagnostics, Inc.
K934137	OPUS(R) SEROLOGY CONTROLS, MODIFICATION	Mar 07, 1994	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K925703	OPUS SEROLOGY CONTROLS	Apr 08, 1993	Substantially Equivalent	Pb Diagnostics, Inc.