(67 days)
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No
The summary describes a quality control solution for laboratory analyzers and does not mention any AI or ML components.
No
Explanation: The device is a quality control system intended for checking the precision and accuracy of analyzers, not for treating any medical condition.
No
Explanation: The device, Qualicheck 4 Metabolite, is described as a quality control system intended for checking the precision and accuracy of analyzers. It is not used to diagnose a patient's medical condition directly.
No
The device description explicitly states it is a "four level quality control system consisting of part numbers S3630, S3640, S3650, and S3660. Each level consists of 30 ampoules per box, 2 mL solution per ampoule," indicating it is a physical solution, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is for "checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate." These analyzers are used to test samples taken from the human body (in vitro) to provide diagnostic information.
- Device Description: It is a "quality control system" used with these analyzers. Quality control materials are essential components of in vitro diagnostic testing to ensure the reliability of the results.
- Predicate Device: The predicate device listed, "K952637 Qualicheck 4 Glucose," is also a quality control material for glucose testing, which is a common IVD test.
Therefore, based on its intended use as a quality control for in vitro diagnostic analyzers, Qualicheck 4 Metabolite fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate."
Product codes
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Device Description
"Qualicheck 4 Metabolite is a four level quality control system consisting of part numbers S3630, S3640, S3650, and S3660. Each level consists of 30 ampoules per box, 2 mL solution per ampoule."
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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RADIOMETER AMERICA INC.
MEDICAL DIVISION
Exhibit VII
811 SHARON DRIVE, WESTLAKE, OHIO 44145-1598
800-738-0600, 216-871-8900
FAX 216-892-8117
JUN 1 4 1996
SUBJECT: 510(k) SUMMARY
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FROM: Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America, Inc. 810 Sharon Drive Westlake. Ohio 44145 (216)871-8900, Ext287 or 1-800-736-0600 Fax (216)871-8117
DATE: April 1, 1996 -
PRODUCT: Trade Name - Qualicheck™4 Metabolite Common Name - Quality Control Classification Name - Controls for Blood Gas (assayed and unassayed)
PREDICATE
DEVICE: Qualicheck 4 Glucose
PRODUCT
DESCRIPTION: Qualicheck 4 Metabolite is a four level quality control system consisting of part numbers S3630, S3640, S3650, and S3660. Each level consists of 30 ampoules per box, 2 mL solution per ampoule.
INTENDED
- USE: Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate.
TECHNOLOGICAL CHARACTERISTICS
VERSUS PREDICATE
DEVICE: Qualicheck 4 Metabolite is technologically similar to Oualicheck 4 Glucose.
SUBSTANTIAL
- EQUIVALENCE: Qualicheck 4 Metabolite is substantially equivalent in features and characteristics to the current Qualicheck 4 Glucose (K952637) marketed by Radiometer America Inc. The only difference is the addition of the lactate analyte.