AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1

K030849 · N-Dia, Inc. · JJX · Feb 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K030849
• Device Name: AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
• Applicant: N-Dia, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended 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.

Device Story

AmniSure is a point-of-care, lateral flow immunochromatographic test; detects Placental alpha-1 microglobulin (PAMG-1) in vaginal secretions. Components include sterile Dacron swab for sampling, solvent vial for extraction, and test strip. Test strip utilizes colloidal gold-labeled mouse monoclonal antibodies; immobilized mouse monoclonal antibodies (test region); rabbit anti-mouse anti-immunoglobulin antibodies (control region). Healthcare professionals perform test at bedside; results interpreted visually. Presence of PAMG-1 indicates amniotic fluid presence; aids clinical diagnosis of ROM. Benefits include rapid, non-instrumented detection compared to traditional pH-based methods.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Lateral-flow immunochromatographic assay; qualitative; non-instrumented. Utilizes monoclonal antibodies for detection of PAMG-1 protein. Form factor is a test strip/cassette. Standalone device; no software or connectivity.

Indications for Use

Indicated for pregnant women > 34 weeks gestation reporting signs, symptoms, or complaints suggestive of fetal membrane rupture (ROM).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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