(18 days)
Not Found
No
The device description and performance studies focus on the stability and reproducibility of a control material for hematology instruments, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is a control for laboratory instruments, not for diagnosing or treating a condition.
No
This device is a control for hematology instruments, used to verify their performance, not to diagnose a patient.
No
The device description clearly states it is a suspension of biological materials packaged in vials, indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is "intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments." Controls are used to verify the performance of in vitro diagnostic tests.
- Device Description: The device is a "suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes." These are biological components used in laboratory testing.
- Context: The device is used with hematology instruments, which are used to perform in vitro diagnostic tests on blood samples.
Therefore, based on the intended use and device description, Para Tech Plus Retics fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.
Product codes (comma separated list FDA assigned to the subject device)
JCN
Device Description
Para Tech Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
Mentions image processing
Not Found
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)
Four studies of Para Tech Plus Retics were conducted: I) Run to Run Reproducibility and Comparison to Whole Blood; II) Site to Site Reproducibility; III) Long Term Stability; and IV) Open Vial Stability. Study results showed Para Tech Plus Retics to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
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.
0
NOV 300 1999
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories, Inc.
P.O. Box 45625
Omaha, NE 68145-0625 |
|-------------------------|--------------------------------------------------------------------------|
| Official Correspondent: | Paul Kittelson
Quality Assurance/Regulatory Affairs
(402) 691-7465 |
| Date Prepared: | November 8, 1999 |
| Names of Device: | |
| Trade Name: | Para Tech Plus Retics |
| Common Name: | Assayed hematology control |
| Classification Name: | White and red cell (and reticulocyte) control (§ 864.8625) |
| Predicate Device: | Para Tech (K896154) manufactured by Streck
Laboratories |
- Description: Para Tech Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
- Intended Use: Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.
- Comparison with Predicate Device: Like Para Tech, Para Tech Plus Retics is intended for CBC/WBC differential performance validation of Bayer Advia 120 and Technicon H-Series hematology instruments. Both devices contain stabilized human red blood cells, human white cells, and simulated platelets which properly mimic human whole blood components on Baver Advia 120 analyzers.
Unlike Para Tech, Para Tech Plus Retics contains a stabilized human reticulocyte component. This allows the Advia user to control CBC, WBC differential, and on-line reticulocyte analysis simultaneously with a single device.
- Discussion of Tests and Test Results: Four studies of Para Tech Plus Retics were conducted: I) Run to Run Reproducibility and Comparison to Whole Blood; II) Site to Site Reproducibility; III) Long Term Stability; and IV) Open Vial Stability. Study results showed Para Tech Plus Retics to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
- Conclusions Drawn From Tests: Para Tech Plus Retics is safe and effective for controlling CBC/Diff/Retic parameters on Bayer Advia 120 and Technicon H-Series instruments 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 U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 30 1999
Mr. Paul Kittelson Ouality Assurance/Regulatory Affairs Streck Laboratories, Inc. 14124 Industrial Road Omaha, Nebraska 68144
Re: K993825 Trade Name: Para Tech Plus Retics Regulatory Class: II Product Code: JCN Dated: November 8, 1999 Received: November 12, 1999
Dear Mr. Kittelson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
3
K 993825
Not Assigned 510(k) Number (if known): __
Para Tech Plus Retics Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use: Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Set E. Maker
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices 14993875
510(k) Number
Prescription Use_V (Per 21CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
October 6, 1999 ---Date __