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.

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.

AI/ML Overview

This document describes the 510(k) submission for Streck Laboratories, Inc.'s "Chem-Chex STAT (New)" device, a multi-analyte control intended for verifying the accuracy of i-STAT chemistry analyzers.

Here's an analysis of the provided information against the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria in a quantifiable manner (e.g., "accuracy must be within X%"). Instead, the "acceptance criteria" appear to be based on demonstrating:

Reproducibility: The device consistently provides the same results under similar conditions.
Substantial Equivalence: The device performs similarly to predicate devices (i-STAT Control and the former Chem-Chex STAT (K96115)).
Stability: The device maintains its performance characteristics over its stated shelf-life.
Fulfillment of Intended Use: The device effectively verifies the accuracy of i-STAT chemistry analyzers.

Acceptance Criteria Category	Reported Device Performance
Reproducibility	"consistently reproducible"
Substantial Equivalence	"substantially equivalent to the predicate products"
Stability	"stable for the entire product dating"
Fulfillment of Intended Use	"fulfills its intended use when used as instructed in the product package insert"
Safety and Effectiveness	"safe and effective product"

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Three studies" were conducted:

lot to lot reproducibility
open and closed vial stability
site to site comparisons at 4 different locations

However, specific sample sizes for each study or for the overall test set are not provided. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a control solution, it's highly likely these were prospective laboratory studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable in this context. The device is a "multi-analyte control" for chemistry analyzers. Its "ground truth" (i.e., the expected values for pH, Na+, Ca++, Cl-, K+, BUN, Hgb, Hct, and Glucose) would be established through robust analytical methods, not by expert human interpretation like in diagnostic imaging. The "assayed" nature of the control implies that these values are determined by quality control testing in a laboratory setting using highly accurate reference methods.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the ground truth is established analytically for a control solution, there is no need for human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The Chem-Chex STAT is a quality control material for an automated analyzer, not a diagnostic tool requiring human interpretation.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

This concept is not directly applicable to a chemistry control solution. The "performance" of the Chem-Chex STAT is its ability to provide stable, reproducible, and accurate values for the analytes it contains, which are then used to verify the performance of an automated i-STAT analyzer. The device itself is not an algorithm, but a physical control material. The "testing" involves chemical analysis.

7. The Type of Ground Truth Used:

The ground truth for Chem-Chex STAT is established through analytical assay/measurement of the specific analytes (pH, Na+, Ca++, Cl-, K+, BUN, Hgb, Hct, and Glucose) within the control solution. The term "assayed chemistry control" directly implies this.

8. The Sample Size for the Training Set:

This information is not applicable. The Chem-Chex STAT is a physical control substance, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable, as there is no "training set" for this device.

Summary

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510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck Laboratories, Inc.14124 Industrial RoadOmaha, Nebraska 68144
Official Correspondent:	Paul KittelsonQuality Assurance Manager

K982290

(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:

Intended Use:

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

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.