(67 days)
No
The summary does not mention AI, ML, or any related terms, and the device description is for a quality control solution, not a software-based diagnostic or analytical tool.
No
The device is described as a quality control system for checking the precision and accuracy of analyzers, not for treating or diagnosing medical conditions.
No
Multicheck™ with metabolite is described as a quality control system intended for checking the precision and accuracy of analyzers, not for diagnosing patient conditions.
No
The device description explicitly states it is a "four level quality control system consisting of part numbers S5530, S5540, S5550, and S5560. Each level consists of 30 ampoules per box, 2 mL solution per ampoule." This describes physical components (ampoules and solutions), not software.
Based on the provided information, 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, Oximetry, Electrolytes, and Glucose and Lactate." These are all parameters measured in biological samples (blood, etc.) using in vitro methods.
- Device Description: It is a "quality control system" used to evaluate the performance of analyzers that test biological samples.
- Predicate Device: The mention of a predicate device, "Multicheck™," which is also a quality control material for blood gas and electrolyte analyzers (as indicated by the reference device K number K952725), further supports its classification as an IVD. Quality control materials for diagnostic tests are considered IVDs.
Therefore, Multicheck™ with metabolite fits the definition of an In Vitro Diagnostic device as it is intended to be used in vitro to assess the performance of diagnostic analyzers that test biological samples.
N/A
Intended Use / Indications for Use
Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose and Lactate.
Product codes
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Device Description
Multicheck™ with metabolite is a four level quality control system consisting of part numbers S5530, S5540, S5550, and S5560. Each level consists of 30 ampoules per box, 2 mL solution per ampoule.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Multicheck (K952725)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K961355 Exhibit
811 SHARON DRIVE, WESTLAKE, OHIO 44145-1698
800-738-0600, 216-871-8900
FAX 216-892-8117
JUN 14 1996
SUBJECT: 510(k) SUMMARY
- Donald L. Baker FROM: 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
- Trade Name Multicheck™ PRODUCT: Common Name - Quality Control Classification Name - Controls for Blood Gas (assayed and unassayed)
PREDICATE
DEVICE: Multicheck™
PRODUCT
- DESCRIPTION: Multicheck™ with metabolite is a four level quality control system consisting of part numbers S5530, S5540, S5550, and S5560. Each level consists of 30 ampoules per box, 2 mL solution per ampoule.
INTENDED
- USE: Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose and Lactate.
TECHNOLOGICAL CHARACTERISTICS
VERSUS PREDICATE
DEVICE: Multicheck™ with metabolite is technologically similar to Multicheck™ with glucose.
SUBSTANTIAL
- EQUIVALENCE: Multicheck™ with metabolite is substantially equivalent in features and characteristics to the current Multicheck (K952725) marketed by Radiometer America Inc. The only difference is the addition of the lactate analyte.
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