FastTake Compact Blood Glucose Monitoring System

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

510(k) Number

K993632 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation Predictor (Cassette)

  Class I

  FDA 510(k) K991466 Active Cleared 25 May 1999

• Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick)

  Class I

  FDA 510(k) K991386 Active Cleared 25 May 1999

• Fasttake Compact Blood Glucose Monitoring System

  Class II

  FDA 510(k) K990939 Active Cleared 20 Apr 1999

• Excel GE Blood Glucose Test Strips & Code Strip

  Class II

  FDA 510(k) K991480 Active Cleared 17 Sep 1999

• Inverness Medical Ovulation Predictor Test

  Class I

  FDA 510(k) K002867 Active Cleared 12 Oct 2000

• Modification to Fasttake Compact Blood Glucose Monitoring System

  Class II

  FDA 510(k) K001427 Active Cleared 2 Jun 2000

See all devices from Selfcare, Inc. →

• Is the FastTake Compact Blood Glucose Monitoring System designed for repeated use by multiple patients, or is it intended for single-patient use only?

  The FastTake Compact Blood Glucose Monitoring System is explicitly designed for single-patient-use only, as stated in the device description. This means each unit is intended to be used once per patient and should not be reused or shared.

• What type of blood sample does the FastTake Compact Blood Glucose Monitoring System require, and how should it be collected?

  The device is designed to measure glucose levels in fresh capillary whole blood, which is typically collected from a small skin puncture (e.g., fingertip). The description specifies it operates outside the body, so no venous or arterial blood samples are required.

• Does the FastTake Compact Blood Glucose Monitoring System require any special storage conditions beyond standard room temperature?

  No, the device does not require special storage conditions beyond those outlined in the manufacturer’s instructions. It is intended for home use and does not mention refrigeration, humidity control, or other environmental restrictions.

• What is the regulatory pathway for the FastTake Compact Blood Glucose Monitoring System, and how does it classify the device?

  The FastTake Compact Blood Glucose Monitoring System holds an FDA 510(k) clearance under the Clinical Chemistry (CGA) product code, classified as a Class II device. The clearance was granted on November 12, 1999, and it is regulated under 21 CFR 862.1345.

• Are there multiple models or sizes available for the FastTake Compact Blood Glucose Monitoring System, or is it a single unified device?

  The provided data does not specify multiple models or sizes for the FastTake Compact system. It is described as a portable, single-patient-use system without mention of variations in design or configuration, implying a unified device.