(14 days)
Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers. It includes assay values for CBC/Diff parameters.
Para® 5X is a tri-level multi-parameter hematology control consisting of stabilized human red blood cells, human white blood cells and simulated platelets. The product is packaged in glass vials containing 3 ml. The closures are polypropylene screw caps with pierceable liners.
The provided text describes the Para® 5X hematology control device, but it lacks specific acceptance criteria (numerical thresholds for performance) and detailed study results that would allow for a comprehensive table of acceptance criteria vs. device performance. The document generally states that "All testing showed that Para 5X is consistently reproducible and performs within the claims."
However, based on the available information, here is an attempt to address the request as best as possible, with significant limitations due to the lack of explicit numerical data in the provided text.
Acceptance Criteria and Study Details for Para® 5X
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., CV% thresholds, bias limits) are not explicitly stated in the provided text, the table below uses descriptive terms based on the general conclusions presented. The reported performance is also described in general terms for the same reason.
| Performance Metric/Test | Acceptance Criteria (Implicit/General) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Consistent and reproducible performance throughout claimed open vial period | Consistently reproducible and performs within claims |
| Long-Term Stability (Shelf Life) | Consistent and reproducible performance throughout claimed shelf life period | Consistently reproducible and performs within claims |
| Alternate/Off-Site Testing | Consistent and reproducible performance in various testing environments | Consistently reproducible and performs within claims |
| Baso % and # addition | Stable and accurate Basophil information integration and measurement for ABX Pentra 60 C+ and Beckman Coulter AcT analyzers | Provides stable Baso information; Consistently reproducible and performs within claims |
| Overall Performance | Safe and effective for controlling counting procedures, performing as claimed | Safe and effective; performs as claimed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for the "Open Vial Stability," "Long-Term Stability (Shelf Life)," or "Alternate/Off-Site Testing" studies. It generally refers to "Studies" being conducted.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. Given the nature of stability and performance testing for a control product, it is most likely a prospective study conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This section is not applicable to this type of device (hematology quality control material). Ground truth for control materials is typically established through extensive characterization and validation using reference methods and statistical analysis within the manufacturer's own quality control processes, rather than by human expert consensus or pathology reports on patient samples.
4. Adjudication Method for the Test Set
This section is not applicable. Since the device is a quality control material whose performance is measured against internal specifications and established reference instrument values, an adjudication method for reconciling expert opinions is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret cases with and without AI assistance. Para® 5X is a quality control material, not an AI-based diagnostic tool for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a sense, the testing described for Para® 5X represents a "standalone" assessment of the control material's performance. The device itself (the control material) is evaluated for its inherent stability and reproducibility on the specified hematology analyzers, independent of human interpretation of patient results. The studies focused on the performance of the control material when processed by the automated analyzers.
7. The Type of Ground Truth Used
The "ground truth" for Para® 5X (a hematology control) would be based on:
- Reference Instrument Measurements: Expected values for CBC/Diff parameters are established by running the control material on validated reference analyzers.
- Methodology-Specific Characterization: Extensive characterization on the target analyzers (ABX Pentra 60 C+ and Beckman Coulter™ AcT™) to establish assay values and acceptable ranges.
- Statistical Analysis: Rigorous statistical methods are used to determine limits for stability, precision, and accuracy, ensuring the material meets its intended quality control function.
- Manufacturing Specifications: The product's formulation and stabilization processes are designed to achieve specific biological properties, which serve as the intrinsic "truth" the control is designed to maintain.
8. The Sample Size for the Training Set
This section is not applicable. Para® 5X is a physical quality control material and not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its development involves chemical and biological formulation, stability studies, and performance characterization, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
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JUN 2 5 2002
Special 510(k): Device Modification Para® 5X - K011410
Summary of Safety and Effectiveness
Streck Laboratories, Inc. 510(k) Submitter: 7002 South 109™ Street La Vista, NE 68128
Official Carol Thompson Quality Assurance/Regulatory Affairs Manager Correspondent: (402) 537-5313
Date Prepared: June 5, 2002
- Names of Device: Trade Name: Para® 5X Assayed hematology control Common Name: Classification Name: Hematology Quality Control Mixture
Predicate Device: STaK-Chex (K911582), manufactured by Streck Laboratories, Inc.
Description: Para® 5X is a tri-level multi-parameter hematology control consisting of stabilized human red blood cells, human white blood cells and simulated platelets. The product is packaged in glass vials containing 3 ml. The closures are polypropylene screw caps with pierceable liners.
Intended Use: Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers. It includes assay values for CBC/Diff parameters.
Design Control Activities: Para 5X has not undergone a formulation or intended use change. Para 5X was evaluated on instrumentation for the ability to provide stable Baso information.
Testing Performed: Studies were conducted to establish performance of Para 5X Baso % and # addition; Open Vial Stability, Long-Term Stability (Shelf Life) and Alternate/Off-Site testing. All testing showed that Para 5X is consistently reproducible and performs within the claims.
Conclusions Drawn from the Tests: Para 5X is a safe and effective product useful for controlling the counting procedures of ABX Pentra 5X C+ and Beckman Coulter AcT hematology analyzers. It will perform as claimed when used in accordance with the package insert instructions.
The brand and product names of the instruments are trademarks of their respective holders
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 5 2002
Mr. Paul Kittelson Quality Assurance Coordinator Streck Laboratories, Inc. 7002 South 109th Street La Vista. Nebraska 68128
K021922 Re: Trade/Device Name: Para® 5X Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology QC Mixture Regulatory Class: II Product Code: JPK Dated: June 5, 2002 Received: June 11, 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman
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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| CALLERS POST PARTICULAR | |
|---|---|
| And Annual Company of Children Company of Childrenof Real Property----------------------------------- |
PARA® 5X
510(k) Number:
Device Name:
Indications For Use:
Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcTTM hematology analyzers. It includes assay values for CBC/Diff parameters.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Date: Date:
Amorphine Bautié
(Division Sidn-Off) Division of Clinical Laboratory Devices
510(k) Number.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, 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.