Urine Chemistry Control, Level 2, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.

Device Description

Urine Chemistry Control. Level 2, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 2 will be offered in 10.0 mL and 25.0 mL fill vials.

AI/ML Overview

The provided text describes a Urine Chemistry Control, Level 2 device, which is a quality control material, not an AI or imaging device. Therefore, many of the requested fields regarding acceptance criteria, study design, expert involvement, and reader studies are not applicable.

Here's the relevant information that can be extracted from the provided document:

1. Acceptance Criteria and Reported Device Performance

For this quality control device, the "acceptance criteria" are primarily related to its design and intended use being substantially equivalent to a predicate device. The "performance" in this context refers to its ability to serve as a quality control material, which is implied by its composition and intended use.

Device Characteristic	Acceptance Criteria / Predicate Device Performance	Reported Device Performance (Urine Chemistry Control, Level 2)
Intended Use	Assayed quality control urine for monitoring precision of laboratory testing procedures. (Predicate: Lyphochek® Quantitative Urine Control, Abnormal)	Assayed quality control urine for monitoring performance of urine chemistry test procedures.
Matrix	Human Urine (Predicate)	Human Urine
Form	Lyophilized (Predicate)	Lyophilized
Analytes	51 analytes (Predicate)	48 analytes of clinical significance that may be found in urine.
Storage	2-8°C (Predicate)	2-8°C
Stability	Until expiration date noted on vial label. (Predicate)	Until expiration date noted on vial label.

Conclusion from document: The device is concluded to be "substantially equivalent" to the predicate device due to the comparison of intended uses and physical properties.

2. Sample size used for the test set and the data provenance

Not applicable. This is a quality control material evaluation, not a diagnostic device with a test set of patient data. The "comparison" was made against a predicate device's characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a test set is not relevant for this type of device submission.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of diagnostic device evaluation. The "ground truth" for this product, if one could apply the term, would be the established performance and characteristics of the predicate device (LYPHOCHEK® QUANTITATIVE URINE CONTROL BIO-RAD Laboratories K-880495) and the standard analytical methods used to verify the composition and stability of the control material itself.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Product Performance and Substantial Equivalency

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _ K 99 8578

SeraCare Technology, Inc. DBA Consolidated Technologies Submitter: 2170 Woodward Street Austin, TX 78744-1832 Phone: (512) 445-5100 (512) 445-5515 Fax:

Rusty Sewell Contact:

Preparation date:

July 28, 1999

Product name (trade & common):

Urine Chemistry Control, Level 2 Proprietary: Common: Not Applicable

Classification name:

Class 1 , Product code: JJW 21 CFR 862:1660 : Urinalysis Controls (Assayed and Unassayed)

Predicate device:

LYPHOCHEK® QUANTITATIVE URINE CONTROL BIO-RAD Laboratories K-880495

Device description:

Intended use:

Urine Chemistry Control. Level 2. is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.

Labeling: Vial labels see Attachments I and II Secondary Container label, see Attachments III and IV Package Insert, see Attachment V

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Product Performance and Substantial Equivalency

510(k) Summary (continued)

Comparative analysis:

The table below provides a summary of the technological characteristics between Urine Chemistry Control and the predicate device.

DeviceCharacteristic	Urine Chemistry Control,Level 2	Lyphochek® Quantitative UrineControl, Abnormal (2)
Intended use	Assayed quality control urine formonitoring performance of urinechemistry test procedures.	Assaved quality control urine formonitoring precision of laboratorytesting procedures.
Matrix	Human Urine	Human Urine
Form	Lyophilized	Lyophilized
Analytes	48 analytes of clinical significancethat may be found in urine.	51 analytes
Storage	2-8°C	2-8°C
Stability	Until expiration date noted on viallabel.	Until expiration date noted on viallabel

Conclusions:

The information provided in the pre-market notification demonstrates that Urine Chemistry Control, Level 2, is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available device. The information supplied in the pre-market notification provides reasonable assurance that Urine Chemistry Control, Level 2, is safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 3 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. DBA, Consolidated Technologies 2170 Woodward Street Austin, Texas 78744-1832

Re: K992578

Trade Name: Urine Chemistry Control, Level 2 Regulatory Class: I Product Code: JJW Dated: July 28, 1999 Received: August 2, 1999

Dear Mr. Sewell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) number (if known): K 992578

Device name: Urine Chemistry Control, Level 2

Indications for use:

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Madsen

(Division Sign-Om
Division of Clinical Laboratory Devices K992578
510(k) Number

Prescription ✓

ﺬ ﻣ

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.