(20 days)
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No
The document describes a quality control material for urinalysis and does not mention any AI or ML components.
No
The device is a quality control material intended to monitor the precision of laboratory testing procedures, not to treat or diagnose a disease.
No
Explanation: The device is described as a "quality control urine" used to "monitor the precision of laboratory dipstick and microscopic testing procedures." It is not used to diagnose a patient's condition but rather to ensure the accuracy of other diagnostic tests.
No
The device is a liquid control material used in laboratory testing, not a software application.
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 dipstick and microscopic testing procedures for the analytes listed in the package insert." This indicates it's used in a laboratory setting to evaluate the performance of other diagnostic tests.
- Device Description: It's a "quality control urine" prepared from biological materials (human urine, erythrocytes, leukocytes) and chemicals. This type of product is specifically designed for use in in vitro diagnostic procedures.
- Intended User / Care Setting: It's intended for use in a "laboratory," which is the typical setting for IVD testing.
- Predicate Device: The mention of a predicate device (K890577; Liquid Urine Control Kenlor Industries) further supports its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for new IVD submissions.
Based on these factors, the Liquichek Urinalysis Control fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
CFR 862.1660
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad. The logo is in black and white, with the words "BIO-RAD" in bold, sans-serif font. The words are stacked on top of each other and enclosed in a rounded rectangle. The logo is simple and modern, and it is likely used to represent the company's brand.
Bio-Rad
Laboratories
S Division
K965/71
ll
.IAN 13 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 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 Westminister, 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
Image /page/1/Picture/0 description: The image shows the logo for BIO-RAD. The logo is in a black rounded rectangle. The text "BIO-RAD" is in white, bold, sans-serif font.
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
机
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 monitor 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 |