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Quicktek Blood Glucose System

by Chronimed, Inc.

510(k) K010039

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010039 Date10 Aug 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, Quicktek Control Solution
510(k) Number
FDA Product Code
NBW
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Quicktek Blood Glucose System is a System, Test, Blood Glucose, Over The Counter device designed for quantitative measurement of glucose levels in blood and other body fluids. It is intended for use in monitoring carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, as well as pancreatic islet cell carcinoma diagnostics.

This system includes a Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, and Quicktek Control Solution, all supplied as a single-use kit. The device received FDA 510K clearance under the NBW product code, classified under the Clinical Chemistry advisory committee, and is intended for home or clinical use. No regulatory status beyond the stated FDA clearance is implied.

Other devices from Chronimed, Inc.

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of conditions can the Quicktek Blood Glucose System help monitor or diagnose?

    The Quicktek Blood Glucose System is designed to measure glucose levels in blood and other body fluids for monitoring carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia. It is also intended for use in diagnosing pancreatic islet cell carcinoma, though this is not its primary clinical application.

  • Is the Quicktek Blood Glucose System intended for home use, or is it primarily for clinical settings?

    The Quicktek Blood Glucose System is explicitly cleared for both home and clinical use, making it versatile for patients managing their glucose levels at home or healthcare providers in a clinical setting.

  • How is the Quicktek Blood Glucose System supplied, and is it reusable?

    The Quicktek Blood Glucose System is supplied as a single-use kit, which includes the Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, and Quicktek Control Solution. This means each kit is intended for one-time use, ensuring sterility and accuracy for individual testing sessions.

  • What regulatory pathway did the Quicktek Blood Glucose System follow to gain market authorization?

    The Quicktek Blood Glucose System received FDA clearance through a 510(k) submission, classified under the NBW (Non-Prescription Blood Glucose Monitoring Systems) product code. It was reviewed by the Clinical Chemistry (CH) advisory committee and determined to be substantially equivalent to a predicate device, following a traditional clearance process.