(14 days)
Not Found
Not Found
No
The document describes a quality control material for laboratory testing and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as an assayed quality control urine to monitor the precision of laboratory testing procedures, not to treat or cure any medical condition.
No
The device is a quality control urine intended to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a liquid control material prepared from human urine with added constituents, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in this package insert." This indicates it's used in a laboratory setting to evaluate the performance of diagnostic tests.
- Device Description: It's a "quality control urine" prepared from biological material (human urine) with added constituents. Quality control materials are a fundamental part of IVD testing.
- Intended User / Care Setting: It's used in "laboratory testing procedures," which is the typical setting for IVD use.
The purpose of this device is to assess the accuracy and reliability of other diagnostic tests performed on urine samples, which is a core function of an IVD quality control material.
N/A
Intended Use / Indications for Use
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Product codes
JJY
Device Description
Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and non-human origin and pure chemicals. The control is provided in liquid form for convenience. This product contains
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad Laboratories, a company that develops, manufactures, and markets a broad range of products and services to the life science research and clinical diagnostics markets. The logo is white text on a black background. The text is in a bold, sans-serif font.
Bio-Rad
Laboratories
m. CA 9. hone (714) 630
June 11, 1997
510(k) Summary
Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 (714)630-6400 Fax (714)666-1383
Contact Person Elizabeth Platt
Date of Summary Preparation May 23, 1997
Device (Trade & Common Name) Liquichek Urine Chemistry Control
Classification Name Class I. 75JJY CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Human Urine Control Quantimetrix Corporation Redondo Beach, CA
Statement of Intended Use
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is written in white, bold, sans-serif letters. The text is set against a black, rounded rectangle.
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue naheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and non-human origin and pure chemicals. The control is provided in liquid form for convenience. This product contains