(48 days)
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No
The document describes a quality control material for validating hCG urine tests. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI/ML. The focus is on the chemical composition and stability of the control material.
No
This device is a control material used to validate the performance of qualitative hCG urine procedures, not to directly treat or diagnose a medical condition.
No
This device is described as a control solution used to validate the performance of qualitative hCG urine procedures and immunochromatographic devices. It does not directly diagnose a condition in a patient; rather, it is used to ensure that other diagnostic devices are functioning correctly.
No
The device description explicitly states the product is manufactured in a liquid matrix solution, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are "intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices" and "to monitor the performance of the specimen while following the specific protocol of the assay being used." This clearly indicates the product is used in vitro (outside the body) to assess the performance of other diagnostic tests.
- Device Description: The description mentions it's a "liquid matrix solution prepared with negative human urine, chemicals, and preservatives," and the positive control is "spiked in a target range of 200-400 mIU of Human Chorionic Gonadotropin per mL of urine." This describes a reagent or material used in a laboratory setting for testing.
- Intended User: The product is intended for "health care professionals," which aligns with the typical users of IVD products in a laboratory or clinical setting.
- Performance Studies: The document describes testing the controls on various "devices listed above" (which are other diagnostic devices) and comparing their performance to "other existing controls in the market." This is characteristic of the validation and performance assessment of an IVD product.
- Predicate Devices: The listing of predicate devices (K965171 Biorad Liquichek, K031231 Biorad Liquichek, K042446 Biorad qUAntity urine controls) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
- Reference Devices: The listing of reference devices (K971886 Unotech Accutest, K972748 Quidel Card QS, K020799 Quickvue) indicates the types of diagnostic devices that this control is intended to be used with, reinforcing its role in the IVD ecosystem.
Based on the intended use, device description, user, and the context of performance studies and predicate/reference devices, the Pregnancy-Skreen™ controls are clearly designed and used as an in vitro diagnostic product for quality control purposes.
N/A
Intended Use / Indications for Use
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 workflowed into the normal quality control regimen as if they were patient "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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K965171, K031231, K042446, K971886, K972748, K020799
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
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.
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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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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
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