(25 days)
The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals. Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Alternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.
The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals.
This document describes the qUAntify™ Control System, a liquid, ready-to-use urine dipstick control. It is intended to determine accuracy and precision in the measurement of physical and chemical tests commonly employed in semiquantitative urine dipstick testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the qUAntify™ device are established by demonstrating substantial equivalence to the predicate device, Kenlor Liquid Urine Control. The performance is deemed acceptable if the observed ranges for various analytes fall within the published ranges of the predicate device.
| Analyte | qUAntify (Level I - Normal) Reported Performance | Kenlor (Level I - Normal) Predicate Range (Acceptance Criteria) | qUAntify (Level II - Abnormal) Reported Performance | Kenlor (Level II - Abnormal) Predicate Range (Acceptance Criteria) |
|---|---|---|---|---|
| Specific Gravity | 1.020 ±.005 | 1.010 ±.005 | 1.010-1.015 | 1.005-1.015 |
| pH | 6 ±.5 | 5.5 ±.5 | 8 | 7-8 |
| Leukocytes | Not reported for Level I | Not reported for Level I | ++ | + |
| Nitrite | Not reported for Level I | Not reported for Level I | + | + |
| Protein | Not reported for Level I | Not reported for Level I | 100 | 100 |
| Glucose | Not reported for Level I | Not reported for Level I | 250-500 | 250-350 |
| Ketones | Not reported for Level I | Not reported for Level I | ++ | ++ |
| Urobilinogen | Not reported for Level I | Not reported for Level I | 1-8 | 1-4 |
| Bilirubin | Not reported for Level I | Not reported for Level I | ++ | +++ |
| Hemoglobin | Not reported for Level I | Not reported for Level I | 250 | 250 |
| HCG | Not reported for Level I | Not reported for Level I | + | + |
Note: The table shows that while most qUAntify ranges align well with or encompass the Kenlor ranges, there are some differences. For instance, qUAntify's Specific Gravity for Level I is higher, pH for Level I is higher, Glucose for Level II has a wider upper range, Leukocytes is "++" for qUAntify vs. "+" for Kenlor, Urobilinogen has a wider range for qUAntify, and Bilirubin is "++" for qUAntify vs. "+++" for Kenlor. The document states that the ranges were "substantially equivalent," implying these differences were considered acceptable for equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "qUAntify was evaluated on several instruments for all 11 analytes." However, it does not specify an exact sample size (e.g., number of batches, number of individual tests performed).
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the address provided for Hematronix, Inc. is in California, USA, it is highly probable the testing was conducted in the USA. The study appears to be retrospective in the sense that the qUAntify data was collected and then compared against the published package insert data of the predicate device, which would also be retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth for this device (urine control) is based on pre-established acceptable ranges of analyte concentrations, which are then used to verify the performance of a new control material.
- The document does not mention the direct involvement of experts in establishing the ground truth for this specific study. Instead, it relied on the published ranges from the predicate device's package inserts.
- Therefore, there is no information provided on the number or qualifications of experts directly involved in establishing the ground truth for this test set; rather, it leveraged existing, published standards from a comparator product.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense (e.g., 2+1 physician review). The evaluation was a direct comparison of the instrument's readings of the qUAntify control against the pre-defined accepted ranges of the predicate device. If readings fell within the expected range, they were considered acceptable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study typically evaluates human performance with and without AI assistance, which is not applicable to a quality control material like qUAntify.
6. Standalone Performance Study
Yes, a standalone performance study was done for the qUAntify device. The document explicitly states: "qUAntify was evaluated on several instruments for all 11 analytes. The ranges observed were compared to published analytes. analy of the same analytes in package inserts provided with Kenlor's Liquid Urine Control." This describes the device (control material) being tested independently to determine its performance characteristics.
7. Type of Ground Truth Used
The type of ground truth used was predicate device performance data. Specifically, the published ranges for the 11 analytes in the package inserts of Kenlor's Liquid Urine Control served as the ground truth or "acceptance criteria" against which qUAntify's observed performance was compared.
8. Sample Size for the Training Set
The document is for a urine dipstick control material, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The control material itself is the "device," and its composition is predetermined, not "trained."
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, the concept of a training set is not applicable to this device. For the control material itself, its "ground truth" (i.e., its expected analyte concentrations and ranges) would have been established during its manufacturing and characterization process, likely through analytical chemistry methods and repeated testing to ensure consistency and assign values. However, the document does not detail this internal process for qUAntify.
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AUG 1 5 1997
Page Al of A3
510(k) Summary
For any questions contact: James D. Lapicola 524 Stone Road Benicia, CA 94510 (707) 746-7833 ext 208 FAX: (707) 746-7837
Date Prepared: July 18, 1997
Gentlemen:
Following is a summary of the basis for a substantially equivalent determination:
| Hematronix Product | |
|---|---|
| Trade Name | qUAntify |
| Common Name | Clinical ChemistryUrine Control |
| Classification Name | Quality Control Materialper 21CFR862.1660 |
Substantially Equivalent Device: Kenlor Liquid Ürine 510 ( k ) Control see #K890577
- is currently "manufactured for" Please note: qUAntify HEMATRONIX, INC. by Kenlor Industries. It is intention to manufacture the material our ourselves.
Device Description/INTENDED USE
The Hematronix qUAntify™ Control System is a liquid, ready-touse, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals.
Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick Alternative tests such as the Glucose (Clinites), testing. Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.
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I
Technological Characteristic Comparison
Both Kenlor's Liquid Urine Control and Hematronix' qUAntify are prepared from human source materials and predetermined chemicals. Two distinct levels are provided to verify the recovery of normal and elevated patient values.
Equivalency between qUAntify and Kenlor Liquid Urine Control
| qUAntify(Applicant) | Liquid Urine Control(Kenlor) | |
|---|---|---|
| Intended Use: | To monitor the:precision systemfor the analyteslisted. | To monitor theprecision systemfor the analyteslisted. |
| MeasurementTechnique: | Semiquantitativetesting and assays | Semiquantitativetesting and assays |
| Analytes: | Specific GravitypHLeukocytesNitriteProteinGlucoseKetonesUrobilinogenBilirubinHemoglobinHCG | Specific GravitypHLeukocytesNitriteProteinGlucoseKetonesUrobilinogenBilirubinHemoglobinHCG |
| Number ofCommon Analytes: | 11 | 11 |
| Matrix: | Human Source Materialsand predeterminedchemicals | Human Source Materialsand predeterminedchemicals |
| Stability: | Unopened Vial2 years at 2°-8°COpened Vial30 days at room temp. | Unopened Vial2 years at 2°-8°COpened Vial30 days at room temp. |
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Non Clinical Performance Data - Conclusions
qUAntify was evaluated on several instruments for all 11 The ranges observed were compared to published analytes. analy of the same analytes in package inserts provided with Kenlor's Liquid Urine Control. The ranges were substantially The data is summmaried in the following table. equivalent.
| qUAntifymfg by HEMATRONIX, INC. | Liquid Urine Controlmfg by Kenlor | |
|---|---|---|
| Level I (Normal): | ||
| Specific GravitypH | 1.020 ±.0056 ±.5 | 1.010 ±.0055.5 ±.5 |
| Level II (Abnormal): | ||
| Specific GravitypHLeukocytesNitriteProteinGlucoseKetonesUrobilinogenBilirubinHemoglobinHCG | 1.010-1.0158+++100250-500++1-8++250+ | 1.005-1.0157-8++100250-350++1-4+++250+ |
Equivalency Ranges as measures of Precision.
Safety and Effectiveness Conclusions:
- qUAntify and Kenlor's MSDS list: 1) sodium azide Safety acts as a constituent (0.05%); and 2) Human blood blood products which is potentially and a biohazardous material. Each blood donor, however, is tested by FDA approved methods for HIV, HCV and HBs Aq.
- As seen in the Non Clinical Performance Effectiveness -Data section above, the qUAntify control system will evaluate the guality of dayto-day test performance when used to determine accuracy and precision in the measurement of the physical and chemical commonly employed in semitests quantitative urine dipstick testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. James D. Lapicola Executive Vice President Hematronix, Inc. 524 Stone Road Benicia, CA 94510
AUG 1 5 1997
K972710 Re : qUAntify Requlatory Class: I Product Code: JJW Dated: July 18, 1997 Received: July 21, 1997
Dear Mr. Lapicola:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. 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 Requlations.
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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 requlation (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 the regulation Chercrea, "Miobranding by rolusios of the 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/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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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:10(k) Number (if known):
)evice Name: qUAntify
ndications For Use:
The Hematronix qUAntify TM Control System is a liquid, ready-to-use urine dipstick No reconstitution or dilution is required. The control is prepared from control. numan source material and predetermined chemicals.
jontrols evaluate the quality of day-to-day test performance. The qUAntify Control ystem is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Ilternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified rine hCG tests. Two distinct levels are included to verify the recovery of normal nd elevated patient values.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
-Off)
Clinical Laboratory Devices
Number K972710
escription Use er 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.