(23 days)
K934641, K96115
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No
The document describes a quality control material for a chemistry analyzer and does not mention any AI or ML components.
No.
Explanation: The device is intended for verifying the accuracy of chemistry analyzers and test cartridges, not for treating any medical condition or disease.
No
Explanation: The device is intended to verify the accuracy of diagnostic devices (i-STAT chemistry analyzers), not to diagnose a patient's condition directly. It functions as a quality control material.
No
The device description clearly states it is a suspension of stabilized mammalian red blood cells in an aqueous buffered medium, packaged in vials. This indicates a physical, non-software component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "verifying the accuracy of i-STAT chemistry analyzers used with i-STAT test cartridges." This is a classic function of a quality control material used in laboratory testing.
- Device Description: It is a "suspension of stabilized mammalian red blood cells in an aqueous buffered medium," packaged in vials. This describes a reagent or control material used in a laboratory setting.
- Assayed Parameters: It is assayed for various chemistry parameters (pH, Na*, Ca**, CIT, K*, BUN, Hgb, Hct, and Glucose), which are common analytes measured by in vitro diagnostic devices.
- Performance Studies: The description of performance studies (lot to lot reproducibility, stability, site to site comparisons) are typical studies conducted for IVD control materials to demonstrate their reliability and consistency.
- Predicate Devices: The predicate devices listed are also control materials used with i-STAT analyzers, further confirming its role as an IVD control.
Therefore, Chem-Chex STAT fits the definition of an in vitro diagnostic device as it is a reagent/material intended to be used in vitro (outside the body) to verify the performance of another IVD device (the i-STAT analyzer and cartridges).
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 i-STAT test cartridges. Chem-Chex STAT is assayed for pH, Na*, Ca**, CIT, K*, BUN, Hgb, Hct, and Glucose.
Product codes
JJY
Device Description
Chem-Chex STAT is a suspension of stabilized mammalian red blood cells in an aqueous buffered medium. Manufactured in three 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 jars.
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 (New) were conducted: () lot to lot reproducibility; 11) open and closed vial stability; and III) site to site comparisons at 4 different locations. Study results showed Chem-Chex STAT (New) to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating.
Key Metrics
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Predicate Device(s)
K934641, K96115
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.
14124 Industrial Road
Omaha, Nebraska 68144 |
|-------------------------|-----------------------------------------------------------------------------|
| Official Correspondent: | Paul Kittelson
Quality Assurance Manager |
(402) 691-7465
June 26. 1998 Date Prepared:
Names of Device:
Trade Name: Common Name: Classification Name: Classification Number: Chem-Chex STAT Assaved chemistry control Multi-analyte control (§862.1660) 75JJY
Predicate Device:
i-STAT control (K934641) manufactured by i-STAT Corp. Chem-Chex STAT control (K96115) manufactured by Streck Laboratory.
Description:
Chem-Chex STAT is a suspension of stabilized mammalian red blood cells in an aqueous buffered medium. Manufactured in three 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 jars.
Intended Use:
Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with i-STAT test cartridges. Chem-Chex STAT is assayed for pH, Na*, Ca**, CIT, K*, BUN, Hgb, Hct, and Glucose.
Comparison with Predicate Devices:
Like the i-STAT Control and former Chem-Chex STAT (96115), Chem-Chex STAT (New) is intended to enable the user to verify satisfactory performance of the i-STAT analyzer and cartridge system. All levels of the device are liquid containing sodium, chloride, potassium, blood urea nitrogen, and glucose.
Like its predecessor control, Chem-Chex STAT (New) is an assayed control that provides the user a complete positive procedural control. It contains red blood cells and is assayed for hemoglobin and hematocrit, it is not assayed for PCO2, or PO2, like the i-STAT.
Discussion of Tests and Test Results:
Three studies of Chem-Chex STAT (New) were conducted: () lot to lot reproducibility; 11) open and closed vial stability; and III) site to site comparisons at 4 different locations. Study results showed Chem-Chex STAT (New) to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating.
Conclusions Drawn from Tests:
Study results show Chem-Chex STAT (New) to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. Chem-Chex STAT (New) is a safe and effective product which fulfills its intended use when used as instructed in the product package insert.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 22 1998
Paul Kittelson Quality Assurance/Regulatory Affairs Manager Streck Laboratories, Inc. 14124 Industrial Road Omaha, Nebraska 68144
K982290 Re : Chem-Chex STAT (New) Regulatory Class: I Product Code: JJY Dated: June 26, 1998 Received: June 29, 1998
Dear Mr. Kittelson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of ' Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: __________ Chem-Chex STAT
Indications For Use:
Chem-Chex STAT is intended to be used for verifying the accuracy of of i-STAT chemistry analyzers used with i-STAT test cartridges. Chem-Chex STAT is assayed for Nat CI · K* BUN, Hgb, Hct, Glucose, pH, and Ca**.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Division " Divi. Jour 14:00 310/k; Aun. Over-The-Counter Use
OR
(Optional Format 1-2-96)