PREGNANCY-SKREEN

K050328 · Biochemical Diagnostic, Inc. · JJX · Mar 29, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050328
• Device Name: PREGNANCY-SKREEN
• Applicant: Biochemical Diagnostic, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Biochemical Diagnostics, Inc., Pregnancy-Skreen™ urine controls are intended to validate the performance of qualitative hCG methods. They should be used as a surrogate specimen while following the specific protocol of the assay being used. This product is intended to be used by health care professionals as an integral part of good laboratory practices.

Device Story

Pregnancy-Skreen™ consists of liquid human urine matrix spiked with chemicals, preservatives, and hCG (for positive control). Positive control target range: 200-400 mIU/mL hCG. Used by healthcare professionals in clinical settings to monitor qualitative performance of hCG immunochromatographic test devices. Controls are processed alongside patient samples following the specific protocol of the assay being used. Results are interpreted visually by the clinician as positive or negative to ensure the test device is functioning correctly. Benefits include quality assurance for pregnancy screening procedures.

Clinical Evidence

No clinical data. Bench testing only: stability studies (real-time) and lot-to-lot comparison testing against released lots and existing market controls.

Technological Characteristics

Liquid matrix; negative human urine base; positive control spiked with 200-400 mIU/mL hCG. Storage 2-8°C. No specific connectivity or software. Manufactured according to GMP.

Indications for Use

Indicated for use by healthcare professionals to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.

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.

Predicate Devices

• Biorad Liquichek (k965171)
• Biorad Liquichek (k031231)
• qUAntity urine controls (k042446)

Submission Summary (Full Text)

{0}------------------------------------------------

K050328

MAR 2 9 2005

## 510K Summary of Safety and Effectiveness of Pregnancy-Skreen™ hCG Liquid Control Urine - Positive and Negative

#### Submitter

Biochemical Diagnostics, Inc. 180 Heartland blvd Edgewood, NY 11717

Telephone: [phone] Fax: [phone]

#### Contact Person

Allen Panetz President Telephone: [phone] E-mail: [e-mail]

#### Date of Summary Preparation

January 27, 2005 Revision - March 17, 2005 Device Identification Product Trade Name: Pregnancy-Skreen™ Common Name: hCG Liquid Control Urine – Negative hCG Liquid Control Urine – Positive Classification: Class I Product Code: JJX Single Regulation Code: 21 CFR 862.1660

#### Description of device

These products are manufactured in a liquid matrix solution prepared with negative human urine, chemicals, and preservatives. The matrix is not known to interfere with any immunoassay procedures including those used in handheld devices. The positive control is spiked in a target range of 200-400 mIU of Human Chorionic Gonadotropin per mL of urine.

#### Intended Use

The Pregnancy-Skreen™ controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.

{1}------------------------------------------------

## Devices to which Substantial equivalence is claimed

Devices to wined Bubstantial of the performance of Biochemical Diagnostics' Pregnancy-Skreen™ wositive and negative controls with the Biorad Liquichek (k965171, k031231) and qUAntity urine controls. (k042446). The Biorad products are multi-constituent whereas Biochemical Diagnostics' control is a single (1012110). The Broad product designed to monitor the qualitative performance of urinalysis test procedures screening for elevated levels of hCG as an early indicator of pregnancy. The above-mentioned controls were tested on three elevated in the or the or the G) test devices. Included were the Unotech Accutest (k971886), the Quidel Card QS (k972748), and the Quickvue (k020799). Device LOD's ranged from 20-25 mIU/mL.

### Acceptance Criteria

The negative and positive Pregnancy-Skreen™ controls were tested from date of manufacture to date of expiration on several devices listed above. They were run side by side with the Biorad Liquichek and qUAntity urine controls that contained hCG as one of the multiple constituents. All controls performed as expected with positive controls reading positive and negative controls reading negative.

New lots of material are run against released lots as well as against other existing controls in the market. Aliquots of the master batch are taken and stored at room temperature (18-25° C) and refrigerated at 2-8° C. testing is performed on day one and day 31. Room temperature testing serves as an accelerated test for stability tioung to partich and enables QC/QA to check for cloudiness that would occur if the batch is contaminated or not properly preserved. Upon acceptance of the master batch the control is dispensed into vials, sampled not property prober it a Clevinning, middle and end of run and tested on hand held devices as previously described. Key customers are periodically surveyed regarding performance of this product.

## Note:

We have been forced to discontinue the quantitative testing of hCG because, to the best of our knowledge, it is we have been to vot commercial reference laboratories. All quantitative testing is currently done on serum. It touger wandline to hand held devices. We feel confident that, considering the screening nature of the oregnancy testing and the wide of results that constitute a positive result, combined with our testing history and acceptance criteria, we are able to product that is well suited to this market without quantitative confirmation.

## Stability

The urine matrix used in Pregnancy-Skreen™ (see description of device) has been used for over eleven years in our Detectabuse™ Liquid Control Urines (k925586). During this period it has proven to impart long-term stability (greater than three years) to all drugs added as well as to naturally occurring compounds. In order to stability (Erculture that and of in this matrix, stability testing was performed over a two year period with a single lot # of each Pregnancy-Skreen™ control. Several other lots of this product were produced and tested from time to time during this period with identical qualitative results (positive or negative) as the long-term test lot. Aliquots of the long term lot of Pregnancy-Skreen™ controls were stored refrigerated at 2-8° C and at room temperature (18-25° C) and tested as shown in the accompanying chart. All supporting data is on file at Biochemical Diagnostics, Inc.

Unopened Shelf Life - Unopened controls, packaged in 5 mL bottles and sampled bi-weekly, were stable for at least 31 days (limit of study) when stored at room temperature (18-25° C) and for two years when stored refrigerated at 2-8° C.

{2}------------------------------------------------

Opened bottle stability – Opened controls were stable for at least 31 days when stored at room temperature Opened bother stability - Opened comments in 31 days). Negatives remained negative and positive and positives (18-25 ℃) of Terrigetated at 2 0 ℃ (Stat) minist to be and sampled by pouring instead of pipetting were stable for two years when stored at 2-8° C.

### Preservatives

Frestraines
Pregnancy-Skreen™ controls (positive and negative) contain Sodium Azide in a concentration of less than Fregirally-Skicel - Controls (positive and negared) of MSDS and listing on the bottle or packaging label.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAR 2 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Allen Panetz President Biochemical Diagnostics, Inc. 180 Heartland Blvd. Brentwood, NY 11717

k050328 Re:

Trade/Device Name: Pregnancy-Skreen TM Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: February 8, 2005 Received: February 9, 2005

Dear Mr. Panetz:

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 encreaty75 the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmeter Fee (1 tor) that the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general voltaren proficturing 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 (QS) regulation (21 CFR Part 820).

{4}------------------------------------------------

#### 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/industry/support/index.html

Sincerely yours,

Jean M. Coogen MS, DUM

Jean 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

{5}------------------------------------------------

# Indications for Use

# 510(k) Number (if known): K050328

# Device Name: Pregnancy-Skreen™ Indications for:

The Biochemical Diagnostics, Inc., Pregnancy-Skreen™ urine controls are inte Bloominiour Diagnomance of qualitative hCG methods. They should be Intendod to valiatio the "specimen while following the specific protocol of the assay being used. This product is intended to be used by health care professionals as an integral part of good laboratory practices.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 791 Subpart C)

Over-The-Counter Use ________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson
Division

n lo Viro Dicio

K050328

Page 1 of