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Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (ALB)

by Hitachi Chemical Diagnostics, Inc.

510(k) K131051

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131051 Date7 Jun 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JGQ
Device Class
Class II
Regulation
21 CFR Part 862.1635
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (ALB) is a turbidimetric reagent cartridge designed for the quantitative determination of total protein and albumin in serum, lithium‑heparinized plasma, K3‑EDTA plasma and sodium citrate plasma. It is used with the Hitachi Clinical Analyzer E40 in clinical chemistry testing.

The cartridge is supplied as a ready‑to‑use unit with a 2D code label that automatically identifies the reagent to the analyzer. It is intended for use in clinical laboratories or physician office laboratories, is classified as a Class 2 medical device and cleared under FDA 510(k) (K131051) as substantially equivalent.

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