(51 days)
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.
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.
The provided text describes the Cal-Chex CD Plus device, an in-vitro diagnostic calibrator for hematology instruments. Let's break down the acceptance criteria and study details based on the information provided.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy > 95%"). Instead, the acceptance criteria are framed around performance characteristics observed in the studies, demonstrating the device's suitability as a calibrator.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Reproducibility | Consistently reproducible in run-to-run studies. |
| Equivalence to Whole Blood Calibration | Substantially equivalent to whole blood calibration methods. |
| Stability (Long Term) | Stable for the entire product dating. |
| Stability (Open Vial) | Stable (implied for entire product dating). |
| Safety and Effectiveness | Safe and effective alternative to Whole Blood Calibration. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the test set in terms of the number of samples or runs. It mentions "Three studies of Cal-Chex CD Plus were conducted," but details on the number of units or measurements within these studies are not provided.
- Sample Size: Not specified quantitatively.
- Data Provenance: Not specified (e.g., country of origin). The studies were conducted by Streck Laboratories, Inc., the manufacturer. It is a retrospective analysis of internal studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. For a calibrator, "ground truth" would typically refer to established reference values or methods for calibration. The document states the device was compared to "whole blood calibration methods," implying these methods served as a reference, but does not detail the process or expert involvement in establishing these reference values.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple experts might disagree on an interpretation, often in imaging or clinical diagnosis. For a quantitative calibrator, the assessment is based on measurements against a reference.
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
This information is not applicable and therefore not provided. MRMC studies and the concept of "human readers improve with AI" are relevant for devices involving human interpretation of data, often in the context of AI-assisted diagnostics. Cal-Chex CD Plus is a calibrator for automated hematology instruments, not a device that assists human readers in interpreting data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This concept is not directly applicable in the same way it would be for an AI algorithm. Cal-Chex CD Plus is the device (a physical calibrator), and its performance is its "standalone" performance when used with the specified hematology instruments. The studies evaluate the performance of the calibrator itself.
7. The Type of Ground Truth Used
The ground truth used for comparison was "whole blood calibration methods." This implies using fresh patient samples calibrated through established and presumably validated laboratory procedures as the reference standard against which the performance of Cal-Chex CD Plus was assessed.
8. The Sample Size for the Training Set
This information is not provided. For a physical calibrator, the concept of a "training set" as understood in machine learning is not directly applicable. The formulation and initial testing of the product would involve extensive internal R&D, but this is not typically framed as a distinct "training set" in the context of device validation for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable in the typical machine learning sense. The "ground truth" for developing the calibrator (its formulation, stability, etc.) would have been established through a combination of scientific principles, laboratory development, and comparison to existing validated calibration methods for hematology parameters.
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APR - 4 2002
KC20469
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories, Inc.PO Box 45625Omaha, 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.
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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
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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
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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:
§ 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.