Product Code: DBL FDA class 2 21 CFR 866.5660

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Immunology

This is an immunological reagent kit for detecting multiple autoantibodies simultaneously using indirect immunofluorescence, providing a substrate antigen and control components for broad-spectrum autoimmune antibody screening in clinical laboratory settings. Simultaneous detection of multiple autoantibodies is useful for evaluating systemic autoimmune diseases such as lupus and mixed connective tissue disease. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DBL, regulated under 21 CFR 866.5660, within the Immunology specialty.

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Basic Information

Product Code: DBL
Device Class: FDA class 2
Regulation Number: 866.5660
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

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 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K180202	Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts	Oct 19, 2018	Substantially Equivalent	Immuno Concepts, N.A. , Ltd.
K980312	NOVA LITE ENDOMYSIAL	Apr 02, 1998	Substantially Equivalent	Inova Diagnostics, Inc.
K974169	WIELISA ANTI-GBM TEST SYSTEM	Feb 17, 1998	Substantially Equivalent	Wieslab AB
K971464	IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT	Oct 29, 1997	Substantially Equivalent	Euro-Diagnostica AB
K971658	MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT	May 23, 1997	Substantially Equivalent	Jay H. Geller
K963525	DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT	Nov 07, 1996	Substantially Equivalent	Shield Diagnostics, Ltd.
K955431	RIT LIVER, KIDNEY, STOMACH IFA KIT	Apr 23, 1996	Substantially Equivalent	The Binding Site, Ltd.
K953495	EIA KIT FOR THE DETECTION OF GBM ANTIBODIES	Apr 10, 1996	Substantially Equivalent	Scimedx Corp.
K944192	ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER	Mar 06, 1995	Substantially Equivalent	Light Diagnostics
K944191	ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER	Mar 06, 1995	Substantially Equivalent	Light Diagnostics
K913360	ANTI-RETICULIN ANTIBODY (ARA) TEST	Sep 26, 1994	Substantially Equivalent	Immco Diagnostics, Inc.
K912551	ANTI-ENDOMYSIAL ANTIBODY TEST	Jun 09, 1993	Substantially Equivalent	Immco Diagnostics, Inc.
K904181	ANTI-GBM ANTIBODIES QUANTITATIVE KIT	Sep 10, 1991	Substantially Equivalent	Biochemical Diagnostic, Inc.
K902237	MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT	Jul 09, 1990	Substantially Equivalent	Medica Corp.
K891099	ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)	Mar 22, 1989	Substantially Equivalent	Immco Diagnostics, Inc.
K891098	ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)	Mar 22, 1989	Substantially Equivalent	Immco Diagnostics, Inc.
K883915	AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)	Oct 19, 1988	Substantially Equivalent	Immco Diagnostics, Inc.
K871194	I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT	Apr 20, 1987	Substantially Equivalent	Cronus
K821576	ANTINUCLEAR ANTIBODY SCREEN FLOURESC	Jun 10, 1982	Substantially Equivalent	Immuno-Products Industries
K820088	AFT SYSTEM PROFICIENCY TESTING PROGRAM	Jan 26, 1982	Substantially Equivalent	Calbiochem-Behring Corp.
K811261	ANTI-SKIN ANTIBODY TEST SYSTEM	Aug 12, 1981	Substantially Equivalent	Zeus Scientific, Inc.
K801960	ANTI-DS/N-DNA TEST KIT	Oct 10, 1980	Substantially Equivalent	Immuno-Diagnostic Products, Inc.
K792610	KALLESTAD FLORESCENT ANA/AMA/ASMA TEST	Feb 22, 1980	Substantially Equivalent	Kallestad Laboratories, Inc.
K791996	MULTIPLE AUTO ANTIBODY TEST	Jan 16, 1980	Substantially Equivalent	Meda Stat Diagnostics, Inc.