X-Cal is a stabilized suspension of human and animal blood, in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4.5 ml. The closures are polypropylene screw caps with polyethylene liners. The vials will be packaged in a five welled vacuum formed "clamshell" container. The product must be stored at 2 - 8℃.

AI/ML Overview

The provided text describes a 510(k) summary for the X-Cal™ Assayed hematology calibrator. It focuses on demonstrating substantial equivalence to a predicate device and does not involve typical acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI device. Instead, the "acceptance criteria" here are implicitly tied to product stability and reproducibility to show it functions similarly to the predicate.

Given the nature of the device (a calibrator) and the provided documentation (a 510(k) summary for substantial equivalence), many of the requested categories for AI/diagnostic studies are not applicable. I will address the relevant points based on the information provided and explicitly state when information is not available or not relevant to this type of device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly Derived)	Reported Device Performance
Intended Use Equivalence	The device's intended use must be similar to the predicate device.	X-Cal: "X-Cal is used to calibrate Sysmex hematology analyzers." Predicate (Cal-Chex): "Cal-Chex is used to calibrate multi-parameter hematology analyzers." (Performance is deemed equivalent for the specified Sysmex analyzers, a subset of the predicate's broader use.)
Open Vial Stability	The open vial stability should be established and acceptable for its intended purpose.	X-Cal Performance: "24 hours" Predicate (Cal-Chex): "5 days" (While different, this is a property of the calibrator, and its 24-hour stability is likely deemed acceptable for routine laboratory use for calibration/verification, as long as it's clearly stated to the user.) Availability of a quantitative metric for this comparison (e.g., % drift from initial values over time) is not explicitly stated but would have been part of the underlying study.
Closed Vial Stability	The closed vial stability should be established and acceptable, demonstrating shelf-life.	X-Cal Performance: "34 days" Predicate (Cal-Chex): "45 days" (Similar to open-vial, a specific stability period is established and deemed acceptable. Actual performance data like % deviation from initial values or target values at 34 days is not explicitly provided in this summary but would be part of the stability study.)
Reagents	Reagents should be similar in composition to the predicate to support equivalence.	X-Cal Performance: "Same" (as predicate) Predicate (Cal-Chex): "Stabilized Human and Animal Blood" (Indicates compositional similarity to predicate was verified.)
Storage Conditions	Storage conditions should be defined and appropriate for maintaining product integrity.	X-Cal Performance: "2 - 8°C" Predicate (Cal-Chex): "2 - 10°C" (Conditions are similar and within acceptable refrigerated ranges.)
Reproducibility	The device should demonstrate consistent "Run to Run Reproducibility."	"Conclusions Drawn From Tests: Study results show X-Cal to be consistently reproducible..." (Specific quantitative metrics for reproducibility are not provided in this summary, but the study concluded it was "consistently reproducible.")
Equivalence to Whole Blood	The performance of the calibrator should be comparable to whole blood for the parameters it calibrates.	"Conclusion: ...and Comparison to Whole Blood" (The study assessed this, and based on the overall conclusion of safety and effectiveness, it was deemed adequate. Specific performance data from this comparison is not provided in the summary.)
Overall Equivalence	The device must be deemed "substantially equivalent" to a legally marketed predicate device, fulfilling its intended use safely and effectively.	"Study results show X-Cal to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. X-Cal is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert." (This is the ultimate conclusion based on all studies performed.)

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

Test Set Sample Size: Not explicitly stated. The text mentions "Three studies of X-Cal were conducted: Run to Run Reproducibility and Comparison to Whole Blood; Open Vial Stability and Closed Vial Stability." However, the number of samples, runs, or batches used in these studies is not provided in this summary.
Data Provenance: Not explicitly stated. Given the context of a US 510(k) submission for a device manufactured by an Omaha, NE-based company (Streck), it is highly probable the testing was conducted in the USA, but no specific country of origin for the data is mentioned. The studies appear to be prospective in nature, as they involve testing the performance and stability of the newly developed X-Cal product.

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

Not Applicable. This device is a calibrator, not an AI or diagnostic device that relies on expert interpretation of images or other data to establish a ground truth. Its performance is measured against instrument readings and stability parameters, which do not inherently require expert "ground truth" in the diagnostic sense. The "ground truth" for calibrators relates to established reference methods or certified reference materials, but these details are not provided in this summary.

4. Adjudication Method for the Test Set

Not Applicable. As noted above, this type of device does not involve expert adjudication for its performance evaluation.

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

Not Applicable. This is not an AI diagnostic device.

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

Not Applicable. This is not an AI diagnostic device. The "standalone performance" of the calibrator would refer to its inherent physical and chemical stability and its ability to produce consistent results on hematology analyzers, which is what the "Run to Run Reproducibility" and stability studies address. It does not involve an algorithm.

7. The Type of Ground Truth Used

For the Open Vial Stability and Closed Vial Stability studies, the "ground truth" would implicitly be the initial measured parameters of the X-Cal product at time zero, against which subsequent measurements at various time points are compared to determine degradation or change within acceptable limits.
For the Run to Run Reproducibility study, the "ground truth" is the inherent consistency expected from a calibrator, often evaluated by parameters like Coefficient of Variation (CV) or standard deviation across multiple runs.
For the Comparison to Whole Blood study, the "ground truth" would be the established values or behavior of whole blood samples measured by the analyzer, against which the calibrator's performance (e.g., its ability to set the calibration curve accurately to yield correct whole blood results) is evaluated.
The comparison to the predicate device (Cal-Chex) uses the known performance characteristics of Cal-Chex as a reference point for demonstrating substantial equivalence.

Specific quantitative "ground truth" values (e.g., target values for specific parameters, acceptable CVs, or deviation limits) are not provided in the summary.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI device, so there is no concept of a "training set."

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

Not Applicable. As there is no training set for this calibrator device.

Summary

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Kof 3200

510(k) Summary of Safety and Effectiveness

510(k) Submitter:

Streck 7002 South 109th Street Omaha, NE 68128

Date Prepared:

October 22, 2008

FEB -3 2009

Names of Device:

Trade Name: Common Name: Classification Names: Classification Numbers: X-Cal™ Assayed hematology calibrator Calibrator for Cell Indices (864.8150) KRX

Cal-Chex- K840261 Predicate Devices:

Description: X-Cal is a stabilized suspension of human and animal blood, in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4.5 ml. The closures are polypropylene screw caps with polyethylene liners. The vials will be packaged in a five welled vacuum formed "clamshell" container. The product must be stored at 2 - 8℃.

Intended Use: X-Cal is used to calibrate and verify calibration of Sysmex hematology analyzers. Refer to product assay sheet.

Comparison with Predicate Devices:

	Cal-Chex (Predicate Product)	X-Cal
Intended UseStatement	Cal-Chex is used to calibratemulti-parameter hematologyanalyzers	X-Cal is used to calibrate Sysmexhematology analyzers.
Open Vial Stability	5 days	24 hours
Closed Vial Stability	45 days	34 days
Reagents	Stabilized Human and AnimalBlood	Same
Storage Conditions	2 - 10°C	2 - 8°C

Discussion of Tests: Three studies of X-Cal were conducted: Run to Run Reproducibility and Comparison to Whole Blood; Open Vial Stability and Closed Vial Stability.

Conclusions Drawn From Tests: Study results show X-Cal to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. X-Cal 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 Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Streck Inc. c/o Ms. Erin Johnson Quality Assurance Coordinator 7002 South 109th St. Omaha, NE 68128

FEB - 3 2009

Re: K083200

Trade/Device Name: X-CalTM Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for Cell Indices Regulatory Class: Class II Product Code: KRX Dated: January 09, 2009 Received: January 12, 2009

Dear Ms. Johnson:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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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Page 2 - Ms. Erin Johnson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.

ia m. chan

Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known):

K083200

Device Name: X-Cal™

Indication For Use:

X-Cal is used to calibrate and verify calibration of Sysmex hematology analyzers.
Refer to product assay sheet Refer to product assay sheet.

Prescription Use _ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Josephine Bautista

Division Sign, Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082202

Regulation Number and Section

§ 864.8150 Calibrator for cell indices.

(a)
Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). 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.