(322 days)
The AmniSure™ ROM (Rupture Of [fetal] Membranes) Test is a rapid, noninstrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women. AmniSure detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM in pregnant women at > 34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM.
Not Found
The provided text is a 510(k) Premarket Notification from the FDA for a device called "AmniSure™ ROM (Rupture of [fetal] Membranes) Test". While it outlines the device's intended use and FDA approval, it does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using only the information provided. The document primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
To answer your questions, I would need access to the actual study report or the detailed premarket notification submission that would contain such information.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 2 2004
Michael Friedman, MBA, Ph.D. N-Dia, Inc. 30 E. 20th Street, Ste. 501 New York, NY 10003
K030849 Re:
KU50649
Trade/Device Name: AmniSure™ ROM (Rupture of [fetal] Membranes) Test Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX; NQM Dated: October 19, 2003 Received: November 4, 2003
Dear Dr. Friedman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to commerce provision to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Hory therefore, market the general controls provisions of the Act. The I ou may, utcrerore, manes of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is clussified (soo a croyals. Existing major regulations affecting your device can may oe subject to Basil adon as a legulations (CFR), Parts 800 to 895. In addition, FDA oc found in This 21, oncerning 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 that I Dr Hab mace a and regulations administered by other Federal agencies. You must or any I catales 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 (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his icael will anow you to begin maing of substantial equivalence of your device to a legally prematicated predicated. The a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you destions on the promotion and advertising of your device, please contact the Office of of questions on the promise Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may ooutin other getain onal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Corper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director · Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K030849/S001 510(k) Number (if known):
Device Name:
AmniSure™ ROM (Rupture Of [fetal] Membranes) Test
Indications for Use:
The AmniSure™ ROM (Rupture Of [fetal] Membranes) Test is a rapid, noninstrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women. AmniSure detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM in pregnant women at > 34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM.
(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 __
(Per 21 CFR 801.109
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030849
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.