X-CAL

K083200 · Streck · KRX · Feb 3, 2009 · Hematology

Device Facts

• Record ID: K083200
• Device Name: X-CAL
• Applicant: Streck
• Product Code: KRX · Hematology
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8150
• Device Class: Class 2

Intended Use

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

Device Story

X-Cal™ is a stabilized suspension of human and animal blood containing biological salts and anti-microbial preservatives; packaged in 4.6 ml plastic vials. Used by laboratory professionals to calibrate and verify calibration of Sysmex hematology analyzers. Product provides assigned model-specific target values for WBC, WBC-D, RBC, NRBC, Hgb, Hct, and Plt. Calibration performed via Open/Manual sampling mode; changes proportionally reflected in Closed and Capillary modes. Ensures accuracy of hematology analyzer measurements; supports clinical decision-making by maintaining instrument performance standards.

Clinical Evidence

No clinical data. Bench testing only. Reproducibility studies conducted on Sysmex XS-1000, XE-2100, and XT-2000 analyzers using three lots of X-Cal™. Stability verified through 34-day closed vial and 24-hour open vial testing, with parameter recovery within established assay ranges.

Technological Characteristics

Stabilized suspension of human and animal blood; biological salts; anti-microbial preservatives. 4.6 ml plastic vials with polypropylene screw caps and polyethylene liners. Storage 2-8°C. Traceable to reference methods. Calibration via Open/Manual sampling mode on Sysmex analyzers.

Indications for Use

Indicated for the calibration and verification of calibration of Sysmex hematology analyzers.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cal-Chex (K840261)

Submission Summary (Full Text)

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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

l

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 Use<br>Statement | Cal-Chex is used to calibrate<br>multi-parameter hematology<br>analyzers | X-Cal is used to calibrate Sysmex<br>hematology analyzers. |
| Open Vial Stability | 5 days | 24 hours |
| Closed Vial Stability | 45 days | 34 days |
| Reagents | Stabilized Human and Animal<br>Blood | 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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