Retic-Chex Linearity for BC is an assayed linearity control kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.

Device Description

Retic-Chex Linearity for BC is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials, containing 3.0 mL volumes. The device consists of five levels of reticulocyte percentage range from 0 to 29.5%. Closures are injection molded polypropylene screw top caps. The vials are packaged in a welled vacuum formed clam-shell container with the package insert and assay sheet.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Retic-Chex Linearity for BC

This document describes the acceptance criteria and the study that demonstrates the Retic-Chex Linearity for BC device meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary implies that the acceptance criteria are based on achieving comparable stability and performance to the predicate device, Retic-Chex Linearity. The "reported device performance" refers to the conclusions drawn from the conducted studies, indicating that the device met these implicit criteria.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Device)	Reported Device Performance
Closed Vial Stability	105 days	105 days
Open Vial Stability	5 days	5 days
Intended Use	Assess instrument accuracy and verify patient reportable ranges of automated/semi-automated hematology instrumentation capable of enumerating reticulocytes, similar to the predicate.	Fulfills intended use when used as instructed.
Formulation	Similar to predicate, with a difference in retic processing.	Same formula as Retic-Chex Linearity, with the only difference being the way retics are processed.
Storage Conditions	2 - 10°C	2 - 10°C
Reticulocyte Level 1 Range	0.4% - 1.1%	0.4% - 1.1%
Reticulocyte Level 2 Range	4.4% - 5.6%	4.7% - 6.8%
Reticulocyte Level 3 Range	8.6% - 10.0%	9.5% - 12.0%
Reticulocyte Level 4 Range	12.7% - 14.4%	14.2% - 17.2%
Reticulocyte Level 5 Range	23% - 25%	26.5% - 29.5%
Reproducibility	Consistently reproducible performance	Consistently reproducible
Equivalence	Substantially equivalent to the predicate product	Substantially equivalent
Overall Stability	Stable for the entire product dating	Stable for the entire product dating

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

The provided 510(k) summary does not explicitly state the sample sizes used for the test sets in the "Run to Run Reproducibility and Comparison to Whole Blood," "Long Term Stability," and "Open Vial Stability" studies.

Similarly, the data provenance (e.g., country of origin of the data, retrospective or prospective) is not mentioned in the provided text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this device's validation. Retic-Chex Linearity for BC is a linearity control material for automated hematology instruments. Its validation involves instrument performance, stability testing, and comparison to existing controls, rather than human expert interpretation of clinical images or data. Therefore, there are no "experts" in the context of establishing ground truth for a test set as described for imaging or diagnostic devices.

4. Adjudication Method

This information is not applicable as the validation does not involve human interpretation or subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted as this device is a linearity control material for automated instruments, not a diagnostic or AI-assisted interpretation tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study, as understood for AI algorithms, was not conducted. The device itself is a material that is run on automated hematology instruments. The "performance" of the device is its ability to produce consistent and accurate values for reticulocyte percentages across its different levels when run on these instruments, and its stability over time. The studies conducted (reproducibility, long-term stability, open-vial stability) assess the intrinsic properties of the control material, which is analogous to a standalone performance, but not in the context of an "algorithm only" as typically discussed for AI.

7. Type of Ground Truth Used

For the purpose of evaluating Retic-Chex Linearity for BC, the "ground truth" for the reticulocyte percentages at each level would have been established by:

Reference Method Assays: Likely using established, highly accurate laboratory methods for reticulocyte enumeration or by comparison to the established values of the predicate device.
Predicate Device Values: The comparison table clearly shows the expected ranges for each level of the predicate device. The new device's levels are presented with corresponding ranges, implying these ranges serve as the target for the "ground truth" or acceptable performance.
Internal Streck Standards: Internal laboratory standards and established manufacturing specifications would define the target values and acceptable ranges for each level.

Therefore, the ground truth is based on reference method assays and comparison to an established predicate device (Retic-Chex Linearity) with pre-defined analytical ranges.

8. Sample Size for the Training Set

This information is not applicable. As a linearity control material, there is no "training set" in the context of machine learning or AI algorithms for this device. The development and manufacturing process of the control material are based on chemical and biological stabilization techniques, not on data-driven model training.

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

This information is not applicable as there is no training set for this type of device. The formulation and processing of the control material are based on established scientific principles for stabilizing blood components and manufacturing processes, rather than on data-driven ground truth establishment for a training set.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck7002 South 109 th StreetOmaha, NE 68128
Official Correspondent:	Carol ThompsonQuality Assurance Manager(402) 537-5313
Date Prepared:	January 19, 2007
	FEB 2 3 2007
Names of Device:
Trade Name:	Retic-Chex ® Linearity for BC
Common Name:	Hematology Linearity Material
Classification Name:	Hematology quality control mixture (§ 864.8625)

Predicate Devices:

Retic-Chex Linearity manufactured by Streck

Description:

Intended Use:

Comparison with Predicate Devices:

	Predicate - Retic-Chex Linearity	Product - Retic-Chex Linearity forBC
Closed VialStability	105 days	105 days
Open Vial Stability	5 days	5 days
Intended Use	Retic-Chex Linearity is a multi levelcalibration (linearity) assessment kit forreticulocyte counting. It is designed foruse on the following instruments: BayerAdvia 120, Sysmex R-3000, SysmexXE-2100, and Abbott Cell-Dyn 4000.Use of this kit allows users to satisfyCAP requirements and CLIArecommendations to verify patientreportable ranges.	Retic-Chex Linearity for BC is anassayed linearity control kit, whichcan be used to assess theinstrument's accuracy and to verifypatient reportable ranges ofautomated and semi-automatedhematology instrumentation capableof enumerating reticulocytes.
Formulation		Same formula as Retic-ChexLinearity. The only difference is theway the retics are processed.
StorageConditions	2 - 10°C	2 - 10°C
Level 1 range	0.4% - 1.1%	0.4% - 1.1%
Level 2 range	4.4% - 5.6%	4.7% - 6.8%
Level 3 range	8.6% - 10.0%	9.5% - 12.0%
Level 4 range	12.7% - 14.4%	14.2% - 17.2%
Level 5 range	23% - 25%	26.5% - 29.5%

{1}------------------------------------------------

Discussion of Tests and Test Results:

Three studies of Retic-Chex Linearity for BC were conducted:

I) Run to Run Reproducibility and Comparison to Whole Blood; II) Long Term Stability; and III) Open Vial Stability. Study results showed Retic-Chex Linearity for BC to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating.

Conclusions Drawn From Tests:

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

STRECK

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

FEB 2 3 2007

Re: K070199

Trade/Device Name: Retic-Chex Linearity for BX Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: January 19, 2007 Received: January 22, 2007

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.

{3}------------------------------------------------

Page 2 -

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,

Robert M. Becker

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

{4}------------------------------------------------

K070199 510(k) Number (if known):

Retic-Chex® Linearity for BC Device Name:

Indications For Use:

Retic-Chex Linearity for BC is an assayed linearity kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.

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

Page 1 of _ 1

Office of In Vitro Diagnostic Device Evaluation and Safety

K070199

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.