(14 days)
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No
The summary describes a quality control material for hematology analyzers, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is described as a multi-parameter quality control material for hematology analyzers, not a device for treating patients.
No
This device is described as a "quality control material" for hematology analyzers, not a device used to diagnose medical conditions in patients. It's used to check the performance of other diagnostic devices.
No
The device description clearly states it is a physical material (stabilized human red blood cells, human white blood cells, and simulated platelets) packaged in glass vials. It is a quality control material for hematology analyzers, not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers." Quality control materials used with diagnostic instruments to verify their performance are considered IVDs.
- Device Description: The description details the composition of the material (stabilized human blood components) and its packaging, which are typical characteristics of IVD reagents and controls.
- Performance Studies: The mention of performance studies to establish stability and reproducibility further supports its role as a quality control material used in a diagnostic setting.
- Predicate Device: The listing of a predicate device (STaK-Chex) with a K number (K911582) indicates that this device has gone through the FDA's 510(k) clearance process, which is required for many IVDs.
Therefore, the information strongly indicates that Para 5X is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device 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.
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)
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.
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.
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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§ 864.8625 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.
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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 Children | |
| of 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.