QUICKVUE ADVANCE PH AND AMINES GLL TEST

K040008 · Quidel Corp. · CEN · Apr 29, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040008
• Device Name: QUICKVUE ADVANCE PH AND AMINES GLL TEST
• Applicant: Quidel Corp.
• Product Code: CEN · Clinical Chemistry
• Decision Date: Apr 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1550
• Device Class: Class 1

Intended Use

The test contains two colorimetric qualitative tests for use in the characterization of vaginal fluid samples: 1) a pH test that differentiates vaginal fluid pH < 4.7 from vaginal fluid pH ≥ 4.7; and 2) a test that detects elevated levels of volatile amines (> 0.5 mM trimethylamine) in vaginal fluid. The QuickVue Advance pH and Amines gII test contains two colorimetric tests intended for the qualitative detection of elevated vaginal fluid pH (pH ≥ 4.7) and the presence of volatile vaginal fluid amines. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.

Device Story

QuickVue Advance pH and Amines gII test is a qualitative, colorimetric diagnostic tool for bacterial vaginosis. Input: vaginal fluid sample. Operation: pH test uses colorimetric indicator to differentiate pH < 4.7 vs ≥ 4.7; amines test uses BCG film with dried alkali (potassium hydroxide analog) to detect volatile amines > 0.5 mM. Output: visual color change (greenish-blue plus sign) against yellow background if positive; procedural control dot confirms valid test. Used in physician office laboratories or clinical settings by healthcare professionals. Results aid clinical diagnosis of bacterial vaginosis. Benefits: rapid, point-of-care assessment of vaginal fluid characteristics.

Clinical Evidence

Multi-center study of 464 post-pubertal women. Compared QuickVue Advance to Amsel criteria (gold standard) and Nugent Gram stain for reconciliation. Results: 92.0% sensitivity and 95.0% specificity (reconciled). Physician office laboratory study (n=352) showed 99% overall accuracy across negative, positive, and moderate positive samples.

Technological Characteristics

Hand-held card with colorimetric indicators. pH test: nitrazine yellow. Amine test: bromocresol green and sodium aluminate (alkali ink). Qualitative visual readout. No instrumentation required. Standalone device.

Indications for Use

Indicated for post-pubertal women as an aid in the diagnosis of bacterial vaginosis by detecting elevated vaginal pH (≥ 4.7) and volatile amines (> 0.5 mM). Intended for use by healthcare professionals in a clinical setting.

Regulatory Classification

Identification

A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

Predicate Devices

• FemExam TestCard test (K962718)

Submission Summary (Full Text)

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APR 2 9 2004

K040008

#### SUMMARY OF SAFETY AND EFFECTIVENESS XI.

### Product:

QuickVue® Advance pH and Amines gll test

### Manufacturer:

QUIDEL Corporation 10165 McKellar Court San Diego, California 92121 U.S.A.

### Device Classification:

Urinary pH (nonquantitative) test system 21 CFR 862.1550 Class I

#### Intended Use:

The QuickVue Advance pH and Amines all test contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaqinal fluid pH < 4.7 from vaginal fluid pH > 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.

### Principles of the Test:

pH Test: The pH test contains a colorimetric pH indicator, which produces a visual color change within one minute of sample application. When contacted with a vaginal fluid sample at or above pH 4.7, the pH test area produces a distinct greenish-blue plus sign against a vellow background and a greenish-blue procedural control dot in the test area. When contacted with a vaginal fluid sample lower than pH 4.7, the pH test produces only a greenish-blue procedural control dot, within one minute, against a yellow background in the test area. Any test that does not develop a procedural control dot is considered an invalid result.

Amines Test: The QuickVue Advance Amines gll test contains a colorimetric pH indicator, which produces a visual color change within one minute of sample application. The test employs a film of BCG in the yellow test area that is surrounded by a thick black ring covered with a dried alkali analogous to the potassium hydroxide (KOH) used to perform the whiff test. The amines test area produces a distinct greenish-blue plus sign against a yellow background within one minute and a greenish-blue procedural control dot in the test area when contacted with a vaginal fluid specimen containing volatile amines at concentrations above 0.5 mM. When contacted with a vaginal fluid specimen that does not contain alkali volatilizable amines test produces a greenishblue procedural control dot against a yellow background in the test area (within one minute). Any test that does not develop a procedural control dot is considered an invalid result.

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# Safety and Effectiveness:

Numerous studies were undertaken to validate the performance characteristics and the substantial equivalence of the QuickVue Advance pH and Amines gll test. These studies included the following:

- The test was shown to have excellent intra- and inter-assay precision. 1.
- Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable. 2.
- Potentially interfering substances were shown not to interfere. ന്
- A multi-center field clinical study was conducted. Sensitivity, specificity and overall 4. accuracy relative to the Amsel criteria with resolution by Gram stain were calculated.
- ம் Physicians' Office Laboratory studies were conducted to show that physician office personnel could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States.

# Conclusion:

These studies demonstrated the substantial equivalence of the QuickVue Advance pH and Amines gll test to existing products already marketed, including the FemExam TestCard test [510(k) K962718], also sold under the brand name QuickVue Advance pH and Amines test. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# APR 2 9 2004

Ms. Jennifer S. Hankard Regulatory Affairs Manager Quidel Corp. 10165 McKellar Ct. San Diego, CA 92121

Rc: k040008

Trade/Device Name: QuickVue® Advanced pH and Amines gII test Regulation Number: 21 CFR 862.1550 Regulation Name: Urinary pH (nonquantitative) test system Regulatory Class: Class I Product Code: CEN Dated: March 24, 2004 Received: March 30, 2004

Dear Ms. Hankard:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 (OS) regulation (21 CFR Part 820).

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# Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device 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 Division of Small Manufacturers, International 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. Cooper, MS, DVM.

Tean 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

510(k) Number (if known): __ K040008

QuickVue® Advance pH and Amines gll test Device Name:

Indications For Use:

The QuickVue Advance pH and Amines gll test contains two colorimetric tests intended for the qualitative detection of elevated vaginal fluid pH (pH ≥ 4.7) and the presence of volatile vaginal fluid amines. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.

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)

ielb. Sarl

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 040008