(25 days)
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No
The document describes a liquid control solution for urine dipstick testing and does not mention any AI or ML components.
No
This device is a control system for evaluating the quality of urine dipstick test performance, not for treating any condition or disease.
No
The device is described as a "urine dipstick control" used to evaluate the quality of laboratory tests and determine accuracy and precision, rather than directly diagnosing a patient's condition.
No
The device description explicitly states it is a liquid control system prepared from human source material and chemicals, 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 clearly states that it is a "urine dipstick control" used to "evaluate the quality of day-to-day test performance" and "determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing." This indicates it is used in vitro (outside the body) to assess the performance of other diagnostic tests.
- Device Description: The description confirms it is a "liquid, ready-to-use, urine dipstick control" prepared from "human source material and predetermined chemicals." This further supports its use as a control for in vitro diagnostic testing.
- Anatomical Site: The anatomical site is listed as "Urine," which is a biological sample tested in vitro.
- Performance Studies: The summary of performance studies describes evaluating the control on instruments for various analytes, comparing ranges to a predicate device (another IVD control). This is typical for the evaluation of an IVD control.
- Predicate Device: The listing of a predicate device (K890577 Kenlor Liquid Urine Control) which is also a urine control, strongly suggests that this device falls under the same regulatory category as an IVD.
In summary, the device is designed to be used in vitro to assess the performance of other diagnostic tests that analyze biological samples (urine). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hematronix qUAntify TM 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 ystem 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.
Product codes (comma separated list FDA assigned to the subject device)
JJW
Device Description
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 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.
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
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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)
qUAntify was evaluated on several instruments for all 11 analytes. The ranges observed were compared to published analytes of the same analytes in package inserts provided with Kenlor's Liquid Urine Control. The ranges were substantially equivalent.
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.
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.
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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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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 Chemistry |
| Urine Control | |
| Classification Name | Quality Control Material |
| per 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.
1
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 system
for the analytes
listed. | To monitor the
precision system
for the analytes
listed. |
| Measurement
Technique: | Semiquantitative
testing and assays | Semiquantitative
testing and assays |
| Analytes: | Specific Gravity
pH
Leukocytes
Nitrite
Protein
Glucose
Ketones
Urobilinogen
Bilirubin
Hemoglobin
HCG | Specific Gravity
pH
Leukocytes
Nitrite
Protein
Glucose
Ketones
Urobilinogen
Bilirubin
Hemoglobin
HCG |
| Number of
Common Analytes: | 11 | 11 |
| Matrix: | Human Source Materials
and predetermined
chemicals | Human Source Materials
and predetermined
chemicals |
| Stability: | Unopened Vial
2 years at 2°-8°C
Opened Vial
30 days at room temp. | Unopened Vial
2 years at 2°-8°C
Opened Vial
30 days at room temp. |
2
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.
| qUAntify
mfg by HEMATRONIX, INC. | Liquid Urine Control
mfg by Kenlor | |
|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Level I (Normal): | | |
| Specific Gravity
pH | 1.020 ±.005
6 ±.5 | 1.010 ±.005
5.5 ±.5 |
| Level II (Abnormal): | | |
| Specific Gravity
pH
Leukocytes
Nitrite
Protein
Glucose
Ketones
Urobilinogen
Bilirubin
Hemoglobin
HCG | 1.010-1.015
8
++
+
100
250-500
++
1-8
++
250
- | 1.005-1.015
7-8
100
250-350
++
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other, with 'Public' on the top line, 'Health' on the second line, and 'Service' on the bottom line.
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
5
: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)