(51 days)
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Not Found
No
The device description and performance studies focus on the stability and reproducibility of a calibrator suspension, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a calibrator for hematology instruments, not for diagnosing, treating, or preventing disease in patients.
No
The device is a calibrator for hematology instruments, used to ensure the accuracy of measurements, not to diagnose a patient's condition.
No
The device description explicitly states it is a suspension of stabilized human blood cells packaged in glass vials, indicating it is a physical substance and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is used as a calibrator for hematology instruments (Abbott Cell-Dyn 3200 and 4000). Calibration is a crucial step in ensuring the accuracy of diagnostic tests performed on these instruments.
- Device Description: The device is a suspension of biological components (human red blood cells, white blood cells, and platelets) intended to be used in vitro (outside the body) with the hematology instruments.
- Function: Calibrators are used to establish the relationship between the instrument's signal and the actual concentration or value of the analyte being measured in a patient sample. This is a fundamental aspect of in vitro diagnostic testing.
Therefore, based on its intended use and function in calibrating diagnostic instruments, Cal-Chex CD Plus fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cal-Chex CD Plus is used to calibrate the WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) parameters on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.
Product codes (comma separated list FDA assigned to the subject device)
81KRZ, 81KRY and 81GLQ
Device Description
Cal-Chex CD Plus is a suspension of stabilized human red blood cells, human white blood cells, and human platelets packaged in glass vials containing 3.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in a PVC clamshell.
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 Cal-Chex CD Plus were conducted:
- I. Run-to-Run Reproducibility and Comparison to Whole Blood
- II. Long Term and Open Vial Stabilities;
- III. Verification as a calibrator. Study results showed Cal-Chex CD Plus to be consistently reproducible, substantially equivalent to whole blood calibration methods and stable for the entire product dating.
- Study results show Cal-Chex CD Plus to be consistently reproducible and stable for the entire product dating. Cal-Chex CD Plus is a safe and effective alternative to Whole Blood Calibration when utilized 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.
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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.
0
APR - 4 2002
KC20469
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories, Inc.
PO Box 45625
Omaha, NE 68145 |
| ------------------- | -------------------------------------------------------------- |
|---|
March 21, 2002 Date Prepared:
Names of Device:
Cal-Chex CD Plus Trade Name: Assaved hematology calibrator Common Name: Calibrator for hemoglobin or hematocrit measurement (§864.8165) Classification Names: Calibrator for platelet counting (§864.8175) Hematology quality control mixture (§864.8625) 81KRZ, 81KRY and 81GLQ Classification Numbers:
Cal-Chex manufactured by Streck Laboratories, Inc. Predicate Devices:
Description: Cal-Chex CD Plus is a suspension of stabilized human red blood cells, human white blood cells, and human platelets packaged in glass vials containing 3.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in a PVC clamshell.
- Intended Use: Cal-Chex CD Plus is intended to be used as a calibrator for the calibration of WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.
- Comparison with Predicate Devices: Like Cal-Chex CD Plus is a product utilized to calibrate hematology instrumentation for specified parameters.
Unlike Cal-Chex, Cal-Chex CD Plus utilizes a formulation that has been optimized for use as a calibrator on Abbott Cel-Dyn® Systems employing Multiple Angle Polarized Scatter Separation (MAPSS™) technology.
Discussion of Tests: Three studies of Cal-Chex CD Plus were conducted:
- I. Run-to-Run Reproducibility and Comparison to Whole Blood
- II. Long Term and Open Vial Stabilities;
- III. Verification as a calibrator. Study results showed Cal-Chex CD Plus to be consistently reproducible, substantially equivalent to whole blood calibration methods and stable for the entire product dating.
- Study results show Cal-Chex CD Plus to be Conclusions Drawn From Tests: consistently reproducible and stable for the entire product dating. Cal-Chex CD Plus is a safe and effective alternative to Whole Blood Calibration when utilized as instructed in the product package insert.
1
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, creating a sense of depth and unity.
APR = 4 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Paul Kittelson Quality Assurance/Regulatory Affairs Streck Laboratories, Inc. 7002 South 109th Street La Vista, Nebraska 68128
K020469 Re: Trade/Device Name: Cal-Chex CD Plus Regulation Number: 21 CFR § 864.8150 Regulation Name: Calibrator for Cell Indices Product Code: KRX Regulatory Class: II Regulation Number: 21 CFR § 864.8165 Regulation Name: Calibrator for Hemoglobin or Hematocrit Measurement Product Code: KRZ Regulatory Class: II Regulation Number: 21 CFR § 864.8175 Regulation Name: Calibrator for Platelet Counting Product Code: KRY Regulatory Class: II Regulation Number: 21 CFR § 864.8185 Regulation Name: Calibrator for Red Cell and White Cell Counting Product Code: KSA Regulatory Class: II Dated: February 8, 2002 Received: February 12, 2002
Dear Mr. Kittelson:
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
2
Page 2 - Mr. Paul Kittelson
or any Federal statutes and regulations administered by other Federal agencies. You must of any i citization and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in and quant) 1978. more (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) I mis letter will and w yourse finding of substantial equivalence of your device to a legally prematication of the results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far 0588. Additionally, for questions on the promotion and advertising of Compinatee at (301) 597 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I other general information on your responsibilities under the Act may be obtained from the Other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours, Steven
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number:
Cal-Chex CD Plus
Device Name:
Indications For Use:
Cal-Chex CD Plus is used to calibrate the WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) parameters on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Josephine Buntin
inical Laboratory Devices
510(k) Number K020469
Date: