(96 days)
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No
The summary describes a calibration material for hematology analyzers, which is a chemical/biological reagent, not a software or hardware device that would typically incorporate AI/ML. There is no mention of AI, ML, image processing, or any other technology indicative of AI/ML.
No
X-Cal is used to calibrate and verify calibration of medical devices (hematology analyzers), not to treat patients.
No
Explanation: The device, X-Cal, is used to calibrate and verify calibration of hematology analyzers, not to diagnose medical conditions directly.
No
The device description clearly states that X-Cal is a "stabilized suspension of human and animal blood" and is "packaged in plastic vials." This indicates a physical, biological product, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that X-Cal is used to "calibrate and verify calibration of Sysmex hematology analyzers." This indicates that the device is used in vitro (outside the body) to assess the performance of an instrument used for diagnostic purposes (hematology analysis).
- Device Description: The description mentions it's a "stabilized suspension of human and animal blood" and is used with hematology analyzers. Hematology analyzers are used to perform tests on blood samples, which are in vitro diagnostic procedures.
- Predicate Device: The predicate device listed, K840261 Cal-Chex, is also a calibration material for hematology analyzers, further supporting the classification of X-Cal as an IVD.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Calibration materials for diagnostic instruments fall under this definition as they are essential for ensuring the accuracy and reliability of the diagnostic results.
N/A
Intended Use / Indications for Use
X-Cal is used to calibrate and verify calibration of Sysmex hematology analyzers. Refer to product assay sheet.
Product codes (comma separated list FDA assigned to the subject device)
KRX
Device 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℃.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Three studies of X-Cal were conducted: Run to Run Reproducibility and Comparison to Whole Blood; Open Vial Stability and Closed Vial Stability. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cal-Chex- K840261
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
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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 | ||
| Statement | Cal-Chex is used to calibrate | |
| multi-parameter hematology | ||
| analyzers | X-Cal is used to calibrate Sysmex | |
| hematology analyzers. | ||
| Open Vial Stability | 5 days | 24 hours |
| Closed Vial Stability | 45 days | 34 days |
| Reagents | Stabilized Human and Animal | |
| 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 (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):
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