e-CHECK (XE)™ is intended to be used as a control for complete blood cell count (CBC), white blood cell differential, reticulocyte and nucleated red blood cell (NRBC) parameters on Sysmex XE - series instruments.

Device Description

e-CHECK (XE) is a suspension of stabilized human and animal blood packaged in dlass vials, containing 4.6 mL volumes. Closures are injection molded polypropylene screw top caps. The device will consist of three levels: Low CBC/High Retic (Low Level), Normal CBC/Intermediate Retic (Normal Level), and High CBC/Low Retic (High Level).The vials are packaged in a welled vacuum formed clam-shell container with the package insert and assav sheet.

AI/ML Overview

Here's an analysis of the provided text regarding the e-CHECK (XE)™ device, structured according to your requested information.

It's important to note that the provided 510(k) summary is for a hematology control mixture, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study methodologies you'd expect for an AI device (like sensitivity, specificity, human reader improvement for MRMC studies, or ground truth established by expert consensus on images) are not applicable here. The focus for this control device is on its stability and reproducibility in mimicking human blood parameters for calibration and quality control of laboratory instruments.

Device: e-CHECK (XE)™ (Assayed hematology control)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Lot to Lot Reproducibility (consistent performance across manufacturing batches)	Study results showed e-CHECK (XE) to be consistently reproducible
Long Term Stability (performance over the product's shelf life)	Study results showed e-CHECK (XE) to be stable for the entire product dating
Open Vial Stability (performance after opening the vial for use)	Study results showed e-CHECK (XE) to be stable.
Substantial Equivalence to Predicate Device (e-CHECK)	Study results showed e-CHECK (XE) to be substantially equivalent to the predicate products
Fulfillment of Intended Use (control for CBC, WBC diff, reticulocyte, NRBC parameters on Sysmex XE-series)	e-CHECK (XE) is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

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

The 510(k) summary does not explicitly state the sample sizes used for the studies (Lot to Lot Reproducibility, Long Term Stability, and Open Vial Stability). It also does not specify the data provenance in terms of country of origin or whether it was retrospective or prospective, though general "study results" are mentioned, implying prospective testing of manufactured lots.

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

This information is not applicable or provided in the context of this device. For a hematology control mixture, the "ground truth" is typically established by certified laboratory reference methods and the specific parameters measured on the Sysmex XE-series instruments. It's not about expert interpretation of complex data like medical images.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective assessments, which is not relevant for a hematology control.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This is a hematology control device, not an AI-powered diagnostic tool, so reader performance improvement with AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical control substance, not an algorithm. Its performance is measured directly by laboratory instruments when the control is run.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is implicitly based on:

Reference Methods: The established values for CBC, white blood cell differential, reticulocyte, and NRBC parameters on the relevant Sysmex XE-series instruments, determined through highly accurate and calibrated laboratory methods.
Predicate Device Performance: Performance data from the existing e-CHECK predicate device serves as a baseline for substantial equivalence.
Stability Definitions: Defined limits for acceptable variation over time and under different handling conditions.

8. The Sample Size for the Training Set

This information is not applicable or provided. The concept of a "training set" applies to machine learning algorithms. This device is a manufactured biological control.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided. As mentioned above, there's no "training set" in the context of this device. The development of such a control material involves formulation, stabilization, and then extensive testing to characterize its properties against established laboratory standards to ensure it consistently delivers expected values on the target instruments.

Summary

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510(k) Summary of Safety and Effectiveness

K0632/8

SEC 1 4 2006

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:	Carol ThompsonQuality Assurance Manager(402) 537-5313
Date Prepared:	December 5, 2006
Names of Device:
Trade Name:	e-CHECK (XE)TM
Common Name:	Assayed hematology control
Classification Name:	Hematology quality control mixture (§ 864.8625)
Predicate Devices:	e-CHECK manufactured by Streck

Description:

Intended Use:

Comparison with Predicate Devices:

Like e-CHECK, e-CHECK (XE) is intended to enable the user to verify satisfactory performance of Sysmex XE Series hematology instruments in recovery of CBC and white cell differential parameters on whole blood specimens. Both devices contain stabilized human red blood cells, human white cells, and simulated platelets, which properly mimic human whole blood components on Sysmex analyzers.

Unlike e-CHECK, e-CHECK (XE) contains simulated human nucleated red blood cells (NRBCs). This allows the user to verify proper performance of NRBCs on the Sysmex XE - 2100. The addition to NRBC is the difference between the two products.

Discussion of Tests and Test Results:

Three studies of e-CHECK (XE) were conducted:

I) Lot to Lot Reproducibility and Comparison to Whole Blood; II) Long Term Stability; and III) Open Vial Stability. Study results showed e-CHECK (XE) to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating.

Conclusions Drawn From Tests:

Study results show e-CHECK (XE) to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. e-CHECK (XE) is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

STRECK C/O Kerrie Oetter 7002 South 109th Street Omaha, NE 68128

JEC 1 4 2006

Re: K063218

Trade/Device Name: e-CHECK Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: December 5, 2006 Received: December 6, 2006

Dear Ms. Oetter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Toba R. Beckerf

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC

: : : : :

HFZ-404 510(k) Staff HFZ- 440 Division D.O.

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510(k) Number (if known): K063218

Device Name: e-CHECK (XE)™

Indications For Use:

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista

Division/Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

310(k) K063218

Page 1 of __1

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.