(58 days)
Not Found
Not Found
No
The summary describes a specimen collection kit for diagnostic testing and contains no mention of AI or ML.
No
The device is described as a "specimen collection kit" for "in vitro diagnosis" and "diagnostic testing," which indicates a diagnostic rather than a therapeutic purpose.
Yes
The device is described as a "Collection Kit... utilized in situations where an in vitro diagnosis is warranted in obtaining cytology specimens for Chlamydial diagnostic testing." This indicates its use in the diagnostic process.
No
The device is described as a "Direct Specimen Collection Kit," which inherently implies physical components for collecting a specimen, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the kit is "utilized in situations where an in vitro diagnosis is warranted in obtaining cytology specimens for Chlamydial diagnostic testing." The phrase "in vitro diagnosis" is the key indicator.
While the other sections are "Not Found," the intended use alone is sufficient to classify this device as an IVD. It is designed to collect specimens for testing that will be performed outside of the body (in vitro) to diagnose a condition (Chlamydia trachomatis).
N/A
Intended Use / Indications for Use
The SAFETEX Chlamydia trachomatis Direct Specimen Collection Kit is utilized in situations where an in vitro diagnosis is warranted in obtaining cytology specimens for chlamydial diagnostic testing.
Product codes
HHT, LIO
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPT. OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither_Road Rockville MD 20850
DEC 1 1 1998
Natalie Sarraf Andwin Scientific 6636 Variel Avenue Canoga Park, CA 91303
Re:
K983599
Trade Name: Safetex Chlamydia Trachomatis Specimen Collection Kit
Trade Name: Safetex Chiamydia Trachomatis Specimen Collection Kit Regulatory Class: II Product Code: HHT and LIO Dated: October 12, 1998 Received: October 14, 1998
Dear Ms. Sarraf:
Dour his and We have reviewed your Section 510(k) nother is marter to legally marketed above and we have determined the device is substantially 28, 1976, the enactment
predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment proicate devices marketed in interstate comments of to thiry bey 17, 2014
date of the Medical Device Amendments or to devices that have been reclassified in date of the Medical Device Amendments of to devices man Cosmetic Act (Act). You
accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act. accordance with the provisions of the Federal Pood, Drug, Lute Covisions of the Act.
may, therefore, market the device, subject to the general controls provisions of the Act. may, therefore, market the device, subject to the general condonis provins as components
However, you are responsible to determine that the medical devices you use as compone However, you are responsible to determined as substantially equivalent under the premarket prior to in the kit have either been determined as substantially on the market prior to May
notification process (Section 510(k) of the act), or were legally on the more: If you notification process (Section 510(k) of the Medical Device Amender If your 28, 1976, the enactment date of the Medical Devices) and further process (e.g.,
purchase your device components in bulk (i.e., unfinished) and further process (e.g., purchase your device components in bulk (1.6, including these components in ( - ) ( it The First The First The First The sterilize) you must submit a new 510(K) before includes armual registration, listing of
general controls provisions of the Act include requirements for annual registrating general controls provisions of the Act include requirements for alluments
devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n and the many of any big the same has the reach additional sontrols. Existing If your device is classified (see subject to such additional controls. Existing major
(Premarket Approval) it may be subject to such additional control stations, (Premarket Approval) it may be subject to such in the Code of Federal Regulations, Title 21,
regulations affecting your device can be found in the Code of Federal Regulations regulations affecting your device can be nound determination assumes compliance with the Parts 800 to 895. A substantialy equivements, as set forth in the Quality System
Current Good Manufacturing Practice requirements, as set forth in the Quality System Current Good Manufacturing Practice requirences: General regulation (21 CFR Part 820) and that,
Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) an Regulation (QS) for Medical Devices: General regulation (DV S 100)
through periodic QS inspections, FDA will verify such assumptions. Failure to comply with
1
Page 2 - Natalie Sarraf
the GMP regulation may result in regulatory action. In addition, the Food and Drug
er in the states of the form and concerners sensements soncerning your device in the GMP regulation may result in regulator announcements concerning your device in the Administration (FDA) may publish turuler announcements to motification submission does
Federal Register. Please note: this response to your premarket notification submissi Federal Register. Please note: uns response or society of 531 through 542 of the Act for not affect any obligation you might have under scolons 991 and the Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) This letter will allow you to began maiscants beginatial equivalence of your device and thus, ne premarket notification. The FUA iniding of substanced of a more of the may be and thus, permits your device to proceed to the market.
If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance
additionally 809.10 for in vitto diagnostic devices of a seconomian ad advertisi additionally 809.10 for my yilly the questions on the promotion and advertising of your at (301) 594-4588. "Additionally, for questiance at (301) 594-4639. Also, please note the device, please contact the Office of Compilation of comprises notification in obtained from the regulation entitled, "Misoranung of responsibilities under the Act may be obtaince from the Other general information of your responsions at its toll free number (800) 638-2041 or (301)
Division of Small Manufacturers Assistance at its toldsmannain btml" Division of Small Manufactures "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
J.D., MBA
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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SECTION 10: 510(k) Indications for Use
510(k) Number (if known): K983599
Device Name: SAFETEX Chlamydia trachomatis Specimen Collection Kit
Indication(s) for Use: The SAFETEX Chlamydia trachomatis Direct Specimen Collection Kit
ed the same of the same in sites discreasis is warranted in obtaining cytology speci Indication(s) for Use: "The SAFH LX Chianyons is warranted in obtaining cytology specimens
is utilized in situations where an in vitro diamosis is warranted in obtaining cyto is unitzed in simanons weblamydial diagnostic testing.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR , Over-the-Counter Use __
Wordy Dubois
(Division Sign-Off)
510(k) Number
12