The Pregnancy-Skreen™ controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
The Biochemical Diagnostics, Inc., Pregnancy-Skreen™ urine controls are intended to validate the performance of qualitative hCG methods. They should be used as an external quality control to monitor the performance of 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.

Device Description

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria for the Pregnancy-Skreen™ hCG Liquid Control Urine, based on the provided text:

Device: Pregnancy-Skreen™ hCG Liquid Control Urine - Positive and Negative

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance Validation (Substantial Equivalence): Controls should perform as expected when tested against predicate devices and on target diagnostic devices.	All controls performed as expected with positive controls reading positive and negative controls reading negative when tested side-by-side with predicate controls (Biorad Liquichek (K965171, K031231) and qUAntity urine controls (K042446)) on three elevated hCG diagnostic test devices (Unotech Accutest (K971886), Quidel Card QS (K972748), and Quickvue (K020799)).
New Lot Performance: New lots of material must perform comparably to released lots and other existing controls in the market.	New lots are stated to be run against released lots and other existing controls, implying comparable performance. (Specific data for new lots not detailed, but the acceptance states they perform as expected).
Room Temperature Stability (Accelerated Testing): Controls stored at room temperature (18-25°C) should maintain performance and show no cloudiness (indicating contamination).	Unopened controls were stable for at least 31 days (limit of study) when stored at room temperature (18-25°C). The testing serves to check for cloudiness. Opened controls were stable for at least 31 days when stored at room temperature (18-25°C).
Refrigerated Stability: Controls stored refrigerated at 2-8°C should maintain performance over a specified period.	Unopened controls were stable for two years when stored refrigerated at 2-8°C. Opened controls, when sampled by pouring (not pipetting) were stable for two years when stored at 2-8°C.
Qualitative Result Consistency: Positive controls should consistently read positive, and negative controls should consistently read negative.	During stability testing across various lots, identical qualitative results (positive or negative) were observed as the long-term test lot. All controls performed as expected (positive controls positive, negative controls negative).
Matrix Integrity: The liquid matrix solution should not interfere with immunoassay procedures.	The matrix is described as "not known to interfere with any immunoassay procedures." (This is more of a characteristic assertion than a tested criterion, but it's part of the device description).
Preservative Efficacy: Preservatives (Sodium Azide) should prevent contamination without exceeding specified concentrations.	Controls contain Sodium Azide in a concentration less than 0.1%, with a statement of being effective. (Implied efficacy through stability and absence of cloudiness observations).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The exact number of individual control units or tests performed is not explicitly stated as a single "sample size." However, the study involved:
- Testing the negative and positive Pregnancy-Skreen™ controls (presumably multiple units/aliquots) "from date of manufacture to date of expiration."
- Side-by-side testing with two predicate Biorad controls (Liquichek and qUAntity).
- Testing on three different hCG diagnostic test devices (Unotech Accutest, Quidel Card QS, and Quickvue).
- Stability testing across multiple lots (including a single long-term lot over two years, and "several other lots" tested periodically). Aliquots were sampled bi-weekly for unopened stability and an unspecified frequency for opened stability.
Data Provenance: Retrospective (though the ongoing stability testing and customer surveys have prospective elements for continuous monitoring). The data was generated by the manufacturer, Biochemical Diagnostics, Inc., in the USA (Edgewood, NY).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is a quality control material, not a diagnostic test being evaluated for accuracy against a clinical ground truth. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists interpreting images) does not directly apply here.

The "ground truth" for the controls themselves is inherent in their formulation:

The negative control is prepared with negative human urine, meaning it should inherently test negative for hCG.
The positive control is spiked with hCG in a target range of 200-400 mIU/mL, meaning it should inherently test positive for hCG within assays sensitive to this range.

The "experts" involved would be the quality control and R&D personnel at Biochemical Diagnostics, Inc. who formulated these controls and designed the testing protocols. Their qualifications would likely include expertise in immunoassay development, quality control, and analytical chemistry, but specific credentials are not provided.

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) was described because the primary assessment for quality control materials is whether they perform as expected on established qualitative assays. The "ground truth" is known by design (negative control contains no hCG, positive control contains hCG). The observation is a simple qualitative 'positive' or 'negative' result from the assay.

The study simply states, "All controls performed as expected with positive controls reading positive and negative controls reading negative." This indicates direct observation of assay results against the known expected outcome for each control.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically used for diagnostic imaging or interpretation devices where human readers evaluate cases with and without AI assistance. This device is a quality control material for in vitro diagnostic tests, not a diagnostic test itself, and does not involve human reader interpretation. Therefore, no MRMC study was conducted, and no effect size for human reader improvement is applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a reagent (control material), not an algorithm or an automated system. Its "performance" is its ability to elicit the expected positive or negative result when run on a diagnostic test device. The study evaluated this standalone performance of the control material using existing diagnostic test devices. There is no "human-in-the-loop" concept for the control material itself; rather, it's used by humans (laboratory professionals) to validate other diagnostic tests.

7. The Type of Ground Truth Used

The ground truth used is primarily design-based or manufactured ground truth:

Negative Control: Composed of human urine confirmed to be negative for hCG.
Positive Control: Human urine matrix spiked with a known concentration of hCG (200-400 mIU/mL).

This is a form of analytical ground truth, where the composition and expected behavior of the control material are known parameters established during its formulation.

8. The Sample Size for the Training Set

This question is not applicable. The Pregnancy-Skreen™ is a quality control material, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of model development.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this type of device.

Summary

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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: 631-595-9200 Fax: 631-595-9204

Contact Person

Allen Panetz President Telephone: 631-595-9200 E-mail: allen@biochemicaldiagnostics.com

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

Intended Use

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

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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.

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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.

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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).

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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 (240)276-0484. 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 (800) 638-2041 or (301) 443-6597 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

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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

Regulation Number and Section

§ 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.