Dimension Vista Loci Ca 125 Flex Reagent Cartridge,And Dimensions Vista Loci 6 Cal, Model#'s K6455, and KC604

Q: What is the product code of K100321?

The FDA product code is LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125), a Class II (moderate risk) device regulated under 21 CFR 866.6010.

FDA 510(k) K100321 · Siemens Healthcare Diagnostics

Substantially Equivalent

510(k) numberK100321

Submission

Device name: Dimension Vista Loci Ca 125 Flex Reagent Cartridge,And Dimensions Vista Loci 6 Cal, Model#'s K6455, and KC604
Applicant: Siemens Healthcare Diagnostics
Newark, DE, US
Received: February 4, 2010
Decision date: April 12, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.6010
Specialty: Immunology

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K221355	VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional	Ortho Clinical Diagnostics	12/12/2022SE
K200199	ADVIA Centaur CA 125IILTK · Traditional	Siemens Healthcare Diagnostics, Inc.	04/06/2020SE
K143534	Elecsys CA-125 II assayLTK · Traditional	Roche Professional Diagnostics	08/06/2015SE
K142895	LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA…LTK · Traditional	Fujirebio Diagnostics,Inc.	05/21/2015SE
K080469	Vidas Ca 15-3 AssayLTK · Traditional	bioMerieux, Inc.	06/22/2009SE
K080561	Vidas Ca 125 II AssayLTK · Traditional	bioMerieux, Inc.	04/10/2009SE
K072794	Immulite 2500 Om-Ma, Model L5KOPLTK · Special	Siemens Medical Solutions Diagnostics	11/05/2007SE
K042731	Architect Ca 125 II AssayLTK · Traditional	Fujirebio Diagnostics,Inc.	11/19/2004SE

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Questions and answers

When was Dimension Vista Loci Ca 125 Flex Reagent Cartridge,And Dimensions Vista Loci 6 Cal, Model#'s K6455, and KC604 cleared by the FDA?

Dimension Vista Loci Ca 125 Flex Reagent Cartridge,And Dimensions Vista Loci 6 Cal, Model#'s K6455, and KC604 (K100321) received a 510(k) decision of Substantially Equivalent on April 12, 2011, 432 days after the submission was received.

What is the product code of K100321?

The FDA product code is LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125), a Class II (moderate risk) device regulated under 21 CFR 866.6010.