Product Code: JKR FDA class 2 21 CFR 862.1140

Radioimmunoassay, Calcitonin

Clinical Chemistry

This device is a radioimmunoassay system used to measure calcitonin levels in patient serum, used in the diagnosis and monitoring of medullary thyroid carcinoma and other conditions affecting calcium metabolism and thyroid C-cell function. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence, and falls within the Clinical Chemistry specialty under 21 CFR 862.1140. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JKR
Device Class: FDA class 2
Regulation Number: 862.1140
Medical Specialty: Clinical Chemistry
Review Panel: CH
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 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252431	Elecsys Calcitonin	Apr 24, 2026	Substantially Equivalent	Roche Diagnostics GmbH
K182012	ADVIA Centaur Calcitonin (CALCT) assay	Dec 21, 2018	Substantially Equivalent	Axis-Shield Diagnostics Limited
K132828	ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3	Dec 04, 2013	Substantially Equivalent	Roche Diagnostics
K060578	CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)	Aug 30, 2006	Substantially Equivalent	Scantibodies Laboratory, Inc.
K023304	IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL	Dec 09, 2002	Substantially Equivalent	Diagnostic Products Corp.
K990073	CALCITONIN	May 11, 1999	Substantially Equivalent	Kmi Diagnostics, Inc.
K982491	SANGUI BIOTECH, INC. CALCITONIN ELISA KIT	Sep 03, 1998	Substantially Equivalent	Sangui Biotech, Inc.
K964635	NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT	May 21, 1997	Substantially Equivalent	Nichols Institute Diagnostics
K961043	SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)	May 06, 1996	Substantially Equivalent	Scantibodies Laboratory, Inc.
K945961	CALCITONIN IMMUNOASSAY KIT	Nov 20, 1995	Substantially Equivalent	Nichols Institute Diagnostics
K951708	ELSA-HCT	Sep 05, 1995	Substantially Equivalent	Cis-Us, Inc.
K914429	DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)	Jan 15, 1992	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K912536	CALCITONIN KIT MITSUBISHI YUKA	Jul 18, 1991	Substantially Equivalent	Mitsubishi Yuka America, Inc.
K874087	MODIFIED CALCITONIN RIA KIT DSL #1200	Feb 02, 1988	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K872880	CALCITONIN RIA KIT	Aug 13, 1987	Substantially Equivalent	Endocrine Associates, Inc.
K861274	DOUBLE ANTIBODY CALCITONIN RIA KIT	Jun 25, 1986	Substantially Equivalent	Diagnostic Products Corp.
K854240	CALCITONIN RIA KIT	Nov 22, 1985	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K842907	CALCITONIN RADIOIMMUNOASSAY KIT	Sep 05, 1984	Substantially Equivalent	Nichols Institute Diagnostics
K821675	CALCITONIN RIA TEST KIT, DLS 1200	Jun 22, 1982	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K781909	CALCITONIN 125	Jan 10, 1979	Substantially Equivalent	Cambridge Nuclear Radiopharmaceutical