(42 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use are for a quality control material, not a diagnostic or analytical device that would typically incorporate AI/ML.
No
Explanation: The device is described as a quality control material intended for evaluating white blood cell subsets on a flow cytometry instrument, not for treating any medical condition.
No.
CD4 Count is explicitly stated to be a "quality control" material for evaluating instruments, not for diagnosing patient conditions.
No
The device description clearly states it is a suspension of stabilized human blood packaged in a plastic vial, indicating it is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "evaluating white blood cell subsets on a flow cytometry instrument." Flow cytometry is a laboratory technique used to analyze cells, and this device is used in vitro (outside the body) to assess the performance of the instrument used for this analysis.
- Device Description: It's a "suspension of stabilized human blood," which is a biological material used in a laboratory setting for testing or quality control.
- Anatomical Site: It's explicitly stated as "Not Applicable (In vitro diagnostic)," further confirming its use outside the body.
- Indicated Patient Age Range: It's "Not Applicable (Quality control material)," indicating it's not used directly on a patient but rather to ensure the accuracy of tests performed on patient samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the information is about the performance of the flow cytometry instrument used for diagnosis.
N/A
Intended Use / Indications for Use
CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument.
Product codes (comma separated list FDA assigned to the subject device)
GGL
Device Description
CD4 Count is a suspension of stabilized human blood packaged in a plastic vial OD4 Obant 16 a cuppinelon the vials are packaged in a vacuum formed "clam-shell" box.
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 CD4 Count were conducted: 1) Run to Run Reproducibility & Whole Pour Statios of OD F Stability, 3) Closed Vial Stability, and 4) Alternate Site Testing. Study results showed CD4 Count to be consistently reproducible 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.
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
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, NE 68128 |
|-------------------------|-------------------------------------------------------------|
| Official Correspondent: | Carol Thompson, Quality Assurance Manager
(402) 537-5313 |
| Date Prepared: | December 30, 2008 |
| Names of Device: | |
| Trade Name: | CD4 Count |
| Common Name: | Immunophenotyping Control |
| Classification Name: | White Cell Control, 21CFR864.8625 |
| Predicate Device: | CD-Chex® Plus BC (K051633) |
Predicate Device:
Description: CD4 Count is a suspension of stabilized human blood packaged in a plastic vial OD4 Obant 16 a cuppinelon the vials are packaged in a vacuum formed "clam-shell"
Intended Use: ·
box.
CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument
Comparison with Predicate Device:
| | CD-Chex Plus BC
(Predicate Product) | CD4 Count |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use Statement | CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments. | CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument |
| Open Vial Stability | 30 days | Same |
| Closed Vial Stability | 90 days | 60 days |
| Reagents | Contains stabilized human blood in a preservative medium. | Same |
| Storage Conditions | 2 - 10°C | Same |
1
Testing Performed:
Four studies of CD4 Count were conducted: 1) Run to Run Reproducibility & Whole Pour Statios of OD F Stability, 3) Closed Vial Stability, and 4) Alternate Site Testing. Study results showed CD4 Count to be consistently reproducible and stable for the entire product dating.
Conclusions Drawn from the Tests:
Study results show CD4 Count to be consistently reproducible, substantially equivalent i to the predicate product, and stable for the entire product dating. CD4 Count is a safe lo the product, which fulfills its intended use when used as instructed in the product package insert.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Streck Inc. c/o Ms. Kerrie Oetter Ouality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128
FEB 1 1 2009
Re: K083926
Trade/Device Name: CD4 Count Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: GGL Dated: December 30, 2008 Received: December 31, 2008
Dear Ms. Oetter:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
3
Page 2 - Ms. Kerrie Oetter
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria Inchar
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
4
Indication for Use
K083926 510(k) Number (if known):
Device Name: CD4 Count
Indication For Use:
CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Joachim Bautista
Division Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083926