ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 by BIO-RAD | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01

Manufacturer

Date Cleared

1999-03-18

(48 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Liquid Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the anlaytes listed in the value sheet.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, study details, or performance metrics for the Abbott Liquid Urine Chemistry Control device.

The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It discusses regulatory classifications, general controls, and contact information for further inquiries. It also includes the "Indications for Use" for the device.

However, it does not contain any data from a study that would demonstrate the device meets specific acceptance criteria. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested table or answer any of the detailed questions about studies, sample sizes, ground truth, or expert involvement.

Summary

Regulation Number and Section

§ 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.