(87 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 technologies.
No
The device is a control for laboratory instruments, not a device used to treat a disease or condition in a patient.
No.
The device is described as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters, not as a tool to diagnose patients.
No
The device description clearly states it is a suspension of biological materials (red blood cells, white cells, platelets, reticulocytes) packaged in glass 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 it's a "control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters". These are all tests performed in vitro (outside the body) on biological samples (blood).
- Device Description: The description details a "suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes". This is a prepared material designed to be used in laboratory testing.
- Function: Controls are essential components of IVD testing. They are used to verify the accuracy and precision of the testing instrument and reagents.
Therefore, based on its intended use and description as a control material for in vitro blood tests, STaK-Chex Plus Retics fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
STaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell 5-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.
Product codes (comma separated list FDA assigned to the subject device)
GLQ
Device Description
STaK-Chex 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 4.5 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Four studies of STaK-Chex 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 STaK-Chex 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.)
Not Found
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.
STaK-Chex (K911582), Retic-Chex (K905524)
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.
Not Found
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).
Not Found
§ 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 22 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: | August 25, 1999 |
| Names of Device: | |
| Trade Name: | STaK-Chex Plus Retics |
| Common Name: | Assayed hematology control |
| Classification Name: | White and red cell (and reticulocyte) control (§ 864.8625) |
| Predicate Device: | STaK-Chex (K911582) manufactured by Streck Laboratories
Retic-Chex (K905524) manufactured by Streck Laboratories |
| | Description: STaK-Chex Plus Retics is a suspension of stabilized human red blood cells, human |
- D white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.5 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
- Intended Use: STaK-Chex 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 Beckman/Coulter GenS series hematology instruments.
Comparison with Predicate Device: Like STaK-Chex, STaK-Chex Plus Retics is intended for CBC/WBC differential performance validation of Beckman/Coulter GenS hematology instruments. Both devices contain stabilized human red blood cells, human white cells, and simulated platelets which properly mimic human whole blood components on Beckman/Coulter STK-S and GenS analyzers.
Unlike STaK-Chex, STaK-Chex Plus Retics contains a stabilized human reticulocyte component. This allows the GenS 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 STaK-Chex 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 STaK-Chex Plus Retics to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
- Conclusions Drawn From Tests: STaK-Chex Plus Retics is safe and effective for controlling CBC, WBC differential and reticulocyte parameters on Beckman/Coulter GenS instruments when used as instructed in the product package insert.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is black, and the background is white.
NOV 22 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Paul Kittelson Ouality Assurance/Regulatory Affairs Streck Laboratories, Inc. 14124 Industrial Road Omaha. Nebraska 68144
Re: K992887 Trade Name: StaK-Chex® Plus Retics Regulatory Class: II Product Code: GLQ Dated: August 25, 1999 Received: August 27, 1999
Dear Mr. Kettelson:
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 OS 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 Putman
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 (if known): __K992887
Device Name: STaK-Chex® Plus Retics __________________________________________________________________________________________________________________________________________
Indications For Use:
StaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell 5-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992887 |
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)