LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4

• K Number: K052838
• Device Name: LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
• Manufacturer: BIO-RAD
• Date Cleared: 2005-11-09 ( 33 days)
• Product Code: GGM
• Regulation Number: 864.8625
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: K862186

Intended Use

Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Description

This is a liquid product prepared from human whole blood containing preservatives and stabilizers.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Open vial Stability: 14 days at 2°C to 8°C	14 days at 2°C to 8°C
   Shelf Life: 3 years at -10°C to -70°C or 6 months when stored tightly capped at 2°C to 8°C	3 years at -10°C to -70°C or 6 months when stored tightly capped at 2°C to 8°C

2. Sample Size for the Test Set and Data Provenance:
   The document does not explicitly state the sample size used for the stability studies. The data provenance is "retained on file at Bio-Rad Laboratories," indicating it is internal company data, likely retrospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
   Not applicable. This device is a quality control material, and its performance is assessed against predefined stability parameters, not through expert interpretation of data.

4. Adjudication Method for the Test Set:
   Not applicable. The stability studies involve quantitative measurements against established criteria, not subjective expert review.

5. MRMC Comparative Effectiveness Study:
   Not applicable. This is a quality control material, not a diagnostic device that assists human readers.

6. Standalone Performance:
   Yes, the reported performance is for the device standalone, as a quality control material. Its stability characteristics are assessed independently.

7. Type of Ground Truth Used:
   The ground truth is established based on the intrinsic chemical and physical stability properties of the control material under specified storage conditions. This would typically involve laboratory measurements over time to assess the integrity and performance of the analytes within the control.

8. Sample Size for the Training Set:
   Not applicable. This device is a quality control material, not an AI/ML model that requires a training set.

9. How Ground Truth for the Training Set Was Established:
   Not applicable. As noted above, this device does not involve a training set.

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.