HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

K041728 · Immunostics Inc., · JHI · Aug 11, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041728
• Device Name: HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
• Applicant: Immunostics Inc.,
• Product Code: JHI · Clinical Chemistry
• Decision Date: Aug 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Immuno/hCG Detector Combi™ is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine or serum. It is intended for professional and laboratory use only. The immuno/hCG Detector™-Urine is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine. It is intended for professional and laboratory use only. The Immuno/hCG Detector Stix™ is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine. It is intended for professional and laboratory use only.

Device Story

Lateral flow chromatographic immunoassay for qualitative hCG detection; utilizes mouse monoclonal and goat polyclonal antibodies. Input: 150 uL urine or serum sample. Operation: solid-phase sandwich immunoassay; visual interpretation of test lines. Output: qualitative positive/negative result. Used in clinical laboratories and physician’s office laboratories (POL) by professional staff. Provides rapid pregnancy status determination to assist clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison study conducted at three physician office laboratories (POLs) using 141 urine and 120 serum samples for Combi, and 133 urine samples for Urine and Stix versions. Results showed 100% agreement with predicate devices. Analytical sensitivity established at 20 mIU/mL; specificity confirmed against hLH, hFSH, and hTSH; no interference from common substances.

Technological Characteristics

Lateral flow immunoassay for qualitative hCG detection. Form factors include urine test, stix, and combi formats. Professional/laboratory use only. No software or electronic components.

Indications for Use

Indicated for the rapid, qualitative detection of hCG in urine to aid in early pregnancy detection. Intended for professional and laboratory use only.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

## AUG 1 1 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Jeffrey Fleishman Manager, Regulatory Affairs and Quality Assurance Immunostics, Inc. 3505 Sunset Avenue Ocean, NJ 07712

k041728 Re: Trade/Device Name: Immuno/ hCG Detector™- Urine Immuno/hCG Detector Stix™ Immuno/hCG Detector Combi™ Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: June 23, 2004 Received: June 25, 2004

Dear Mr. Fleishman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of 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 encrosale) to regary to regars and the Medical Device Amendments, or to comments from to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been rochasined require approval of a premarket approval application (PMA). alla Cosmetic Act (71ct) market the device, subject to the general controls provisions of the Act. The I ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of uactice, 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 may be subject to such additional controls. Existing major regulations affecting your device It may be subject to such additional controlul controller. The arts 800 to 895. In addition, FDA can be found in Ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase oe advised that I Dri 3 issualles of wordevice complies with other requirements of the Act that IDA has made a decientialions administered by other Federal agencies. You must of any irederal statutes and regulations and limited to: registration and listing (21

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manusing of substantial equivalence of your device to a legally premarket notification: The FDA mining of basification 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 destic specific information associate in the promotion of your contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the In Viro Diagliosite Device Dranation and and one and and incation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You thay ovan buller general miormation. On your 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. Cooper, 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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## Indications for Use

14041798 510(k) Number (if known): Immuno / hCG Detector™ - Urine

Indications for Use:

Device Name: _________________________________________________________________________________________________________________________________________________________________

The Immuno / hCG Detector™ - Urine is for the rapid and qualitative determination of Human The minute / TOO Detocol - Ghine le read an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

Albert S.

Division Sign-

Office of in Vitro Dlagnostic Device Evaluation and Safety

510(k) KC 41728

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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# Indications for Use

510(k) Number (if known):__ KOY]]2XX

Immuno / hCG Detector Stix™ Device Name: __

Indications for Use:

The Immuno / hCG Detector Stix is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

Alberto Seil's

Division Sian-Off

Office of In Vitro Diagnostic Device Evaluation and Sarah

510(k) k041728

Prescription Use A (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Immuno / hCG Detector Combi™ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Immuno / hCG Detector Combi™ is for the rapid and qualitative determination of Human The Milliano 7 TGG Delector Oombil - 18 for the early detection of pregnancy. It is intended for professional and laboratory use only.

Albat Cat's

Division Sign-C

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k041728

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)