FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Clinical Controls LiquiSPx™ Liquid Saliva/Urine Drugs of Abuse Control is a ready-to-use, assayed chemistry control materials for monitoring the accuracy and precision of available analytical procedures. Drug analysis consisting of measuring amphetamine, methamphetamine, phencyclidine, cocaine, tetrahydrocanabinol and morphine is used to assist in the detection and management of drug abuse in at risk patient populations.

Device Description

Liquid Saliva/Urine Drugs of Abuse Control

AI/ML Overview

I am sorry but this document does not contain the information requested. This document is a 510k clearance letter from the FDA to Clinical Controls for their Liquid Saliva/Urine Drugs of Abuse Control device. It confirms that the device is substantially equivalent to previously marketed devices and can be legally marketed.

The document does not provide any details about:

Acceptance criteria for device performance.
The study that proves the device meets acceptance criteria.
Sample sizes, data provenance, expert qualifications, or adjudication methods for any studies.
Information on MRMC studies, standalone performance, or ground truth types.
Details about training sets or how their ground truth was established.

Therefore, I cannot fulfill your request based on the provided text.

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K Number

K012855

Device Name

LIQUISPX LIQUID LIPID CONTROL

Manufacturer

CLINICAL CONTROLS DIVISION

Date Cleared

2001-08-30

(6 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Clinical Controls LiquiSPx Liquid Lipid control is a ready-to-use, assayed chemistry control material for monitoring the accuracy and precision of lipid chemistry control material for monitoring the automated analytical procedures. Lipid analysis consists of measuring total cholesterol, triglycerides, HDL and LDL cholesterol. It is used to assist in the diagnosis and management of LDL cholesterol. This dood to assist in tisk patient populations.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML medical device. The document is an FDA 510(k) clearance letter for a "LiquiSPx Liquid Lipid Control" which is a chemical control material used in laboratory settings, not an AI/ML device. Therefore, I cannot fulfill your request based on the given input.

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K Number

K964278

Device Name

WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6

Manufacturer

CLINICAL CONTROLS, INC.

Date Cleared

1996-11-22

(25 days)

Product Code