LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)

K965171 · Bio-Rad · JJY · Jan 13, 1997 · Clinical Chemistry

Device Facts

• Record ID: K965171
• Device Name: LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of laboratory dipstick and microscopic testing procedures for the analytes listed in the package insert.

Device Story

Liquichek Urinalysis Control is a liquid-form quality control product derived from human urine, supplemented with human erythrocytes, leukocytes, non-human constituents, and pure chemicals. Used in clinical laboratory settings by technicians to monitor the precision of urinalysis dipstick and microscopic testing procedures. The control provides a known reference point to verify the performance of analytical methods. By ensuring the accuracy and precision of these tests, the device assists healthcare providers in maintaining reliable diagnostic results for patient urinalysis, ultimately supporting clinical decision-making regarding patient health status.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Liquid-form control matrix derived from human urine; contains human erythrocytes, leukocytes, and chemical constituents. Level 2 contains 0.1% sodium azide preservative. Storage at 2-8°C. Open vial stability: 2-8°C for 30 days/10 immersions or 18-25°C for 7 days/10 immersions.

Indications for Use

Indicated for use as an assayed quality control material for laboratory personnel to monitor the precision of urinalysis dipstick and microscopic testing procedures.

Regulatory Classification

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.

Predicate Devices

• Liquid Urine Control (K890577)

Submission Summary (Full Text)

{0}

BIO-RAD
Bio-Rad Laboratories
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone [phone]
Toll Free [phone]
K965171
JAN 13 1997

# 510(k) Summary

## Submitter
Bio-Rad Laboratories, ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
[phone]
Fax [phone]

## Contact Person
Elizabeth Platt

## Date of Summary Preparation
December 19, 1996

## Device (Trade & Common Name)
Liquichek Urinalysis Control

## Classification Name
CFR 862.1660: Urinalysis Controls
(Assayed and Unassayed)

## Devices to Which Substantial Equivalence is Claimed
Liquid Urine Control
Kenlor Industries
Westminster, CA
K890577

## Statement of Intended Use
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of laboratory dipstick and microscopic testing procedures for the analytes listed in the package insert.

{1}

BIO-RAD

Bio-Rad Laboratories

ECS Division

3726 E. Miraloma Avenue

Anaheim, CA 92806

Telephone [phone]

Toll Free [phone]

## Description of the Device

Liquichek Urinalysis Control is prepared from human urine with added human erythrocytes, leukocytes and constituents of non-human origin and pure chemicals. The control is provided in liquid form for convenience.

Level 2 of this product contains 0.1% sodium azide as a preservative.

## Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Liquichek Urinalysis Control and the devices to which substantial equivalence is claimed.

| | Bio-Rad Liquichek Urinalysis Control | Liquid Urine Control
Kenlor Industries |
| --- | --- | --- |
| Intended Use | an assayed quality control urine to monitor the precision of laboratory dipstick and microscopic testing procedures for the analytes listed in the package insert | for monitory the accuracy and precision of dipstick and microscopic analysis |
| Form | Liquid | Liquid |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
| Open Vial Claim | 2-8°C for 30 days or 10 immersions; 18-25°C for 7 days or 10 immersions | 2-8°C for 2 weeks or 15 immersions; room temperature for 2 weeks or 10 immersions |