(502 days)
OXP, KIR
Not Found
No
The summary describes a FISH probe kit for detecting chromosomes, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an assay for detecting and enumerating chromosomes in bone marrow samples, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The device detects and enumerates X and Y chromosomes in bone marrow using FISH, which is a method for identifying specific genetic abnormalities or characteristics. This information is used for diagnostic purposes, such as monitoring engraftment in bone marrow transplant recipients. The performance studies also indicate sensitivity and specificity, typical metrics for diagnostic tests.
No
The device description explicitly states it is a "combination of CEP X SpectrumOrange and CEP Y SpectrumGreen continuous DNA probes," which are physical reagents used in the FISH process, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the assay is designed for the "simultaneous detection and enumeration of X and Y chromosomes in interphase nuclei and metaphase spreads in bone marrow by fluorescence in situ hybridization (FISH)." This describes a test performed on a biological sample (bone marrow) outside of the body to provide information about a patient's condition (presence of donor cells after bone marrow transplant).
- Device Description: The description details a "combination of CEP X SpectrumOrange and CEP Y SpectrumGreen continuous DNA probes." These are reagents used in a laboratory setting to perform the FISH assay.
- Anatomical Site: The test is performed on "Bone marrow," which is a biological specimen.
- Performance Studies: The summary of performance studies describes testing on "bone marrow specimens" and evaluating the device's ability to detect the presence of donor cells. This is a clinical evaluation of the device's performance in a diagnostic context.
All of these characteristics 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, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The CEP X/Y probe is a combination of CEP X SpectrumOrange and CRP Y The CEP 7/1 probes is continuous DNA probes for the sights of characters of charmers. region of chromosome X and the sutellite III DNA at the Yq12 region of chromosome Y. This assay is designed to provide a reliable method for the simulancous detection and I mis assay is clesigned to provise and interphase nuclei and metaphase spreads in bone marrow by fluorescence in situ hybridization (FISH).
Product codes
OXP, KIR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
fluorescence in situ hybridization (FISH)
Anatomical Site
bone marrow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
A multi-center, blinded, controlled, comparative study was conducted to characterize the performance of the CEP X/Y probe relative to standard cytogenetic analysis, in recipients of opposite-sex bone marrow transplants (BMT). 143 bone marrow specimens were evaluated at three sites. These specimens were derived from patients with one of the following diagnoses:
- Chronic myelogenous leukemia (CML): 69 specimens
- Chronic myelogenous (AMI.) or Acute nonlymphocytic leukemia (ANLL): 30 specimens
- Myelodysplastic syndrome (MDS): 7 specimens
- Acute lymphoid leukemia (ALL): 21 specimens
- Hematological disorder not otherwise specified, but in which cytogenetics were expected (HDNOS): 16 specimens
All sites utilized unstimulated, cultured specimens for both standard cytogenetic and FISH analyses. Interphase FISH analysis identified 143 out of 143 specimens (100% relative sensitivity) as positive for donor cells, while standard cytogenetic analysis also detected donor cells in 143 out of 143 specimens.
The study also assessed the ability of interphase and metaphase FISH to correctly designate specimens from patients with like-sex BMTs as negative. In 153 patients with like-sex BMTs, interphase FISH designated 149/153 (97.4%) as negative. All four false positive cases occurred in male recipients of like-sex BMT. One case had a 46,X 1,- 1,+X karyotype. The other three cases showed low levels of XX cells (4.6%, 1.6%, and 0.8%). FISH metaphase analysis designated 151/153 (98.7%) as negative, with both false positive metaphase cases being the same patients as those identified by interphase analysis.
Key Metrics
Analytical Sensitivity: The analytical sensitivity of the CEP X/Y probe was tested in the reproducibility study 0.00% (s.d.m0.00%) XY nuclei and the 1% XY specimen 0.94% (s.d.=0.32%). The 0% XX specimen was estimated with a mean of 0.00% (s.d.=0.00%) XX nuclei and 0 % XX specimen, 0.95% (s.d. 34%). There was little overlap between the 0% the 1% & speciment; 0.9% (1% confidence limit for the 1% specimen was 0.31% and 1.28% for XY and XX, respectively. Thus, the limit of detection for CEP X/Y is estimated to be 1.0%.
Analytical Specificity: Locus specificity studies were performed with metaphase spreads according to standard Vysis QC protocols. A total of 65 metaphase spreads were examined sequentially by G-banding to identify chromosomes X and Y, followed by FISH. No crosshybridization to other chromosome loci was observed in any of the 65 cells examined; hybridization was limited to the centromere of chromosome X and the Yq12 region of chromosome Y.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
JAN 2 1 1997
SUMMARY: SAFETY AND EFFECTIVENESS INFORMATION FOR SAFETY AND ERBICTAVERSE Y SpectrumGreen DNA Probe Kit
The CEP X/X probe is a combination of CEP X SpectrumOrange and CRP Y The CEP 7/1 probes is continuous DNA probes for the sights of characters of charmers. region of chromosome X and the sutellite III DNA at the Yq12 region of chromosome Y. This assay is designed to provide a reliable method for the simulancous detection and I mis assay is clesigned to provise and interphase nuclei and metaphase spreads in bone marrow by fluorescence in situ hybridization (FISH).
Standard cytogenetic analysis detects the presence of the X and Y chromosomes by Sundato Cytigenets andysis coose and promosomes with a dye in cultured tissue cells.
Safety and effectiveness issues relevant to FISH assays such as the CEP XY assay may Salely and effectivelies issues resitivity, poor specificity, or poor reproducibility.
Analytical Sensitivity and Specificity
Hybridization Rifficiency
In a pivotal study, the average percentage of cells with only one hybridization signal was 0.012% (S.D.o.15%) on 143 bone marrow specimens. Thus, # Two specimens had no metaphase spreads for FISH analysis, thus the total number was 141, instead of 143.
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The misclassification of a like-sex BMT recipient with an abnormal sequired The misclassincessor of a interportance of performing per-BMT cytogenetic karyotype demonstrates the importance of personing peoples a see by HISH had low levels of XX cells; both recipient and doner cells showed a 40,XX karyotype. low levels of XX couls; bodifferent and conce were misclassified by FISE, low
All levels of donor/recipient colls by FISH should be interpressed with caution. All levels of doner/recupent could by I its a microstion with standard cycles of FISH results should be merpreted in conjunt clinical information.
Conclusions
The porformance of CER XY is suppored by the Vysis Quality Control Procedures and is
demonstrated in clinical studies. When the CEP X SpectumScranger / CRP Y
. Box Can BMA B demonstrated in clinked stoules. Which the OLA 11 Special States statements describe its performance.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Vysis c/o Ms. Vicki Anastasi Manager, Regulatory Affairs 3100 Woodcreek Dr. Downers Grove, IL 60515
AUG 26 2011
Re: K954214 Trade/Device Name: CEP X Spectrum Orange/Y SpectrumGreen DNA Probe Kit Regulation Number: 21 CFR$866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: II Product Code: OXP, KIR Dated: November 19, 1996 Received: November 20, 1996
Dear Ms. Anastasi:
This letter corrects our substantially equivalent letter of January 21, 1997.
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 (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), 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 Parts 801 and
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Page 2 - Ms. Vicki Anastasi
809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mana Eden
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health