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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K253358

510(k) cleared

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay

Diazyme Laboratories, Inc. · Dec 19, 2025 · K253358

FDA cleared the Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay from Diazyme Laboratories, Inc. on Dec 19, 2025 under K253358, a traditional 510(k). The device falls under product code DFH, Kappa, Antigen, Antiserum, Control, regulated at 21 CFR 866.5550 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Sep 30, 2025. The decision came 80 days later, inside the 90 FDA-day goal for a 510(k).

Diazyme Laboratories, Inc. has 2 other decisions in the tracker over the last 12 months: K253069 (Lipoprotein (a) Molarity Assay), K252336 (Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay).

Questions & Answers

What did FDA clear under K253358?

K253358 is the FDA 510(k) for Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay, submitted by Diazyme Laboratories, Inc.. FDA's decision date was Dec 19, 2025, under product code DFH (Kappa, Antigen, Antiserum, Control).

Who makes the Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay?

Diazyme Laboratories, Inc., based in Poway, CA, is the applicant of record for K253358.

How long did the K253358 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 19, 2025, 80 days later.

← All decisions in December 2025

Sources