(49 days)
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No
The description focuses on the chemical composition and physical form of a control solution for a chemistry analyzer, with no mention of AI or ML.
No
This device is intended for verifying the accuracy of chemistry analyzers, not for treating a disease or condition. It is a control solution for quality assurance.
No
The device is a control material used to verify the accuracy of diagnostic devices, not a diagnostic device itself. It is used to ensure the proper functioning of a chemistry analyzer.
No
The device description clearly states it is a suspension of stabilized human red blood cells in an aqueous buffered medium, packaged in vials. This describes a physical, chemical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is used for "verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges." This indicates it is used in vitro (outside the body) to assess the performance of a diagnostic device.
- Device Description: It is a "suspension of stabilized human red blood cells in an aqueous buffered medium," which is a common format for control materials used in laboratory testing.
- Summary of Performance Studies: The studies described focus on "reproducibility," "stability," and "comparison with whole blood," all of which are relevant to the performance and validation of an IVD control material.
- Predicate Device: The mention of a "Predicate Device" with a K number (K934641 i-STAT control) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
Therefore, based on the provided information, Chem-Chex STAT fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges. Chem-Chex STAT is assayed for Na " CI K+ BUN, Hab, Hct, and Glucose.
Product codes
75JJY
Device Description
Chem-Chex STAT is a suspension of stabilized human red blood cells in an aqueous buffered medium. Manufactured in two clinically significant levels, it is packaged in dropper tip polyethylene vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. Vials are packaged in polystyrene iars.
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
Three studies of Chem-Chex STAT were conducted: 1) lot to lot reproducibility and comparison with whole blood; II) within lot reproducibility; and III) long term and open vial stability. Study results showed CVA to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
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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510(k) Summary of Safety and Effectiveness
510(k) Submitter:
Streck Laboratories, Inc. 14306 Industrial Road Omaha, Nebraska 68144
Official Correspondent:
MAY 1 5 1996 Theodore Heise. Ph.D. Quality Assurance/Requlatory Affairs Manager (402) 691-7465
Date Prepared:
March 26, 1996
Names of Device:
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Chem-Chex STAT Assaved chemistry control Multi-analyte control (§862.1660) 75JJY
Predicate Device:
i-STAT control (K934641) manufactured for i-STAT Corp.
Description: Chem-Chex STAT is a suspension of stabilized human red blood cells in an aqueous buffered medium. Manufactured in two clinically significant levels, it is packaged in dropper tip polyethylene vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. Vials are packaged in polystyrene iars.
Intended Use: Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges. Chem-Chex STAT is assayed for Na " CI K+ BUN, Hab, Hct, and Glucose.
Comparison with Predicate Device: Like the i-STAT Control, Chem-Chex STAT is intended to enable the user to verify satisfactory performance of the i-STAT analyzer and cartridge system. Both devices are liquid controls containing sodium, chloride, potassium, blood urea nitrogen, and glucose.
Unlike the i-STAT Control, Chem-Chex STAT is an assayed control. This provides the user a complete positive procedural control. In addition, Chem-Chex STAT contains red blood cells and is assayed for hemoglobin and hematocrit. It is not assayed for PCO2 PO2, pH, or ionized calcium.
Discussion of Tests and Test Results: Three studies of Chem-Chex STAT were conducted: 1) lot to lot reproducibility and comparison with whole blood; II) within lot reproducibility; and III) long term and open vial stability. Study results showed CVA to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating
Conclusions Drawn from Tests: Study results show Chem-Chex STAT to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. Chem-Chex STAT is a safe and effective product which fulfills its intended use when used as instructed in the product package insert.