(139 days)
Not Found
Not Found
No
The summary describes a manual or semi-automated immunoassay for detecting VZV antibodies, with no mention of AI or ML.
No
The device is for in vitro diagnostic use, detecting antibodies to VZV in human serum, which means it aids in diagnosis rather than treating a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and describes its use for "qualitative and semi-quantitative detection of IgG antibodies" as an "aid in the diagnosis of primary infection, or reactivation of VZV".
No
The intended use and device description (or lack thereof) strongly suggest this is an in vitro diagnostic (IVD) kit, which is a physical product containing reagents and potentially hardware components for laboratory testing. The mention of "manual use" and a "semi-automated fluid handler" further supports this. There is no indication of software being the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The first point under "Intended Use / Indications for Use" clearly states: "1. For in vitro diagnostic use only." This is the most direct indicator.
- Nature of the Test: The device is designed to detect antibodies in human serum, which is a biological sample taken from the body and tested in vitro (outside the body).
- Purpose of the Test: The test is used to determine immune status and aid in the diagnosis of VZV infection, which are diagnostic purposes.
The other sections being "Not Found" or "Not Applicable" don't negate the clear indication of "in vitro diagnostic use" and the nature of the test being performed on a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
-
- For in vitro diagnostic use only.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay.
-
- Individual specimens may be used for the determination of immune status.
- Paired (acute / convalescent) sera, may be used to demonstrate seroconversion 4. or significant rises in antibody level, as an aid in the diagnosis of primary infection, or reactivation of VZV.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid 5. handler.
Product codes (comma separated list FDA assigned to the subject device)
LFY
Device Description
Not Found
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)
Not Found
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.
Not Found
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
§ 866.3900 Varicella-zoster virus serological reagents.
(a)
Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Robert A. Cort Vice President, Quality Assurance Quest International 1938 N.E. 148th Terrace North Miami, FL 33181
NOV - 5 1997
Product Code: LFY Dated: September 4, 1997 Received: September 8, 1997
Regulatory Class: II
Trade Name: SeraQuest VAV IgG
Dear Mr. Cort:
Re:
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 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 requirement, 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.
1
Page 2
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 Sutman
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
2
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 163
APPENDIX 11
Page 1 of of
510(k) Number (if known): ____________
Device Name: SeraQuest VZV IqG
Indications For Use:
-
- For in vitro diagnostic use only.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay.
-
- Individual specimens may be used for the determination of immune status.
- Paired (acute / convalescent) sera, may be used to demonstrate seroconversion 4. or significant rises in antibody level, as an aid in the diagnosis of primary infection, or reactivation of VZV.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid 5. handler.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tan Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_14 9702 95
Prescription Use _ し (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
. #278
(Optional Format 1-2-96)