(279 days)
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No
The description focuses on reflectance photometry and visual/instrumental color comparison, with no mention of AI or ML terms or concepts.
No
The device is described as an in-vitro diagnostic test system for analyzing urine, intended to detect conditions and provide diagnostic information, not to treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "qualitative and semi-quantitative analysis" of various substances in urine, and that "Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed." Furthermore, the "Device Description" section states that the device is an "in vitro diagnostic test device."
No
The device description explicitly includes both reagent strips (hardware) and urine analyzers (hardware) which use reflectance photometry (a hardware-based measurement technique). While there is likely software within the analyzers, the overall system is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis..."
- Device Description: The "Device Description" section also states: "Healgen Series Reagent strips for Urinalysis and urine analyzers are in vitro diagnostic test devices..."
- Purpose: The device is designed to analyze biological samples (urine) outside of the body to provide information about a person's health status, which is the core definition of an in vitro diagnostic device.
- Intended Use: The intended use describes detecting conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections, all of which are diagnostic purposes.
N/A
Intended Use / Indications for Use
Healgen Series Reagent Strips for Urinalysis are in vitro diagnostic test devices that use reagents for qualitative and semi-quantitative urinalysis. The strips are for professional use only.
Healgen Series Reagent Strips for Urinalysis are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. The test systems consist of the Healgen Series Reagent Strips (Healgen 10 and Healgen 11) and the Healgen 500 or Healgen 800 Urine Analyzers. The Healgen 10 and 11 strips can be read visually and instrumentally with the Healgen 500 and 800 Analyzers. The Healgen 4 reagent strip can be read visually only. The Healgen Series Urine Reagent Strips and Urine Analyzers are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The Healgen 500 and 800 Urine Analyzers use reflectance photometry to quantitate analyte values from urine samples when using the Healgen 10 and 11 reagent test strips."
Product codes (comma separated list FDA assigned to the subject device)
JIO, JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JMA, JRE, KQO
Device Description
Healgen Series Reagent strips for Urinalysis and urine analyzers are in vitro diagnostic test devices that use reagents for qualitative and semiquantitative urinalysis.
The device is composed of several color pads aligned on a strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.
Healgen Series Reagent Strip provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in 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
professional use only.
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 following are performance characteristics of the Healgen Series Reagent Strips for Urinalysis and Healgen Series Urine Analyzers.
a. Analytical limits (cutoff): We demonstrated the analytical limits of each assay item as below:
Urobilinogen: 0.7 mg/dl
Bilirubin: 0.7 mg/dl
Ketone: 3.5 mg/dl
Blood: 6.5 cells/µL
Protein: 7.2 mg/dl
Nitrite: 50 µg/dL
Leukocytes: 10 cells /µL
Glucose: 65 mg/dl
Ascorbic Acid: 6.5 mg/dl
pH: 5.6
Specific Gravity: 1.003
b. Precision (repeatability/reproducibility): Within-run and within-day precisions were determined at 3 clinical sites by 6 technicians.
In within-run precision testing, 20 replicates were run on each of the 3 levels of urine controls. Each of the 20 replicates was assayed consecutively, using strips obtained from each of 3 lots strips.
In within-day precision testing, the 3 levels were analyzed in duplicate, one a day, for 10 days using strips obtained from 3 lots of strips.
All the 3 formats (Healgen 11, 10 and 4) strips and both of the reading method were used to perform the abovementioned evaluation. For instrumental reading, both Healgen 800 were used.
Urinalysis control Level 1 and Level 2 of Bio-Rad and a 3rd control with analyte concentrations around cutoff were used as samples for lower and higher levels.
The 3rd control was obtained by pooling the Bio-Rad controls and spiking with certain kinds of pure analytes to make all the analyte concentrations near the cutoff values.
c. Reportable ranges: Healgen Series Reagent Strips for Urinalysis are qualitative and semi-quantitative. The strips give results in a small range of concentration of each analyte. All the output values of Healgen Series Reagent Strips are within the laboratory assay ranges. The laboratory assay range and the reportable range of Healgen strips for each analyte are listed in the table.
d. Analytical specificity: The interference study was carried out by adding known amounts of potential interfering substances to urine samples and evaluated the test results. 5 test strips from each of 3 lots were used for each interference test, and all the interferents were tested in a one-at-a-time way. A table of the studied concentrations of the potentially interfering substances that will not have influence on the test results is shown.
e. Comparison Studies Using Clinical Specimens: The clinical comparison studies were conducted in 3 sites using the Healgen 11 Reagent Strip for Urinalysis and the predicate devices. Data obtained by visually reading and instrumental reading (Healgen 500 and 800) were collected. The study results indicated that comparable testing data could be obtained by intended users when using the Healgen 11 Reagent Strip for Urinalysis and the legally marketed URISTK H Series Reagent Strips for Urinalysis from Dirui.
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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§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
K III9999
APR 1 7 2012
510(k) SUMMARY
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.
| Submitted By: | HEALGEN SCIENTIFIC LLC
5213 Maple Street, Bellaire, TX77401 |
|-------------------------|----------------------------------------------------------------|
| Official Correspondent: | Yongguan Wang |
HEALGEN SCIENTIFIC LLC 5213 Maple Street, Bellaire, TX77401 (713) 661-6267
(713) 661-6267
Pr
Telephone FAX
Jul. 10th, 2011 Date Prepared:
Device Name
Trade or Proprietary Name: Healgen Series Reagent Strips and Analyzers for Urinalysis
Common or Usual Name: Urinalysis Test Strips and Analyzers
Device Format
Healgen 11 Reagent Strips for Urinalysis Healgen 10 Reagent Strips for Urinalysis Healgen 4 Reagent Strips for Urinalysis Healgen 500 Urine Analyzer Healgen 800 Urine Analyzer
Classification
| Product Code | Class | Panel | C.F.R. Section |
|---|---|---|---|
| JIO | CLASS II | HEMATOLOGY | 864.6550 |
| JIL | CLASS II | CLINICAL CHEMISTRY | 862.1340 |
| CDM | CLASS I | CLINICAL CHEMISTRY | 862.1785 |
| JJB | CLASS I | CLINICAL CHEMISTRY | 862.1115 |
| JIN | CLASS I | CLINICAL CHEMISTRY | 862.1435 |
| JIR | CLASS I | CLINICAL CHEMISTRY | 862.1645 |
| JMT | CLASS I | CLINICAL CHEMISTRY | 862.1510 |
| LJX | CLASS I | HEMATOLOGY. | 864.7675 |
| CEN | CLASS I | CLINICAL CHEMISTRY | 862.1550 |
| JMA | CLASS I | CLINICAL CHEMISTRY | 862.1095 |
| KQO | CLASS I | CLINICAL CHEMISTRY | 862.2900 |
| JRE | CLASS I | CLINICAL CHEMISTRY | 862.2800 |
Note: Occult blood test and urinary glucose test are the subjects of this submission.
Predicate Device: URISTK H Series Reagent Strips for Urinalysis and Dirui H-50, H-100, or H-500 Urine Analyzer manufactured by Dirui Industrial Co. Ltd (K040703).
Device Description Healgen Series Reagent strips for Urinalysis and urine analyzers are in
vitro diagnostic test devices that use reagents for qualitative and semiquantitative urinalysis.
The device is composed of several color pads aligned on a strip. Each pad is
1
employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.
Healgen Series Reagent Strip provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.
Intended Use/Indications for Use
Healgen Series Reagent Strips for Urinalysis are in vitro diagnostic test devices that use reagents for qualitative and semi-quantitative urinalysis. The strips are for professional use only.
Healgen Series Reagent Strips for Urinalysis are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
Test principles
Urobilinogen: this test is based on the Ehrlich reaction in which p-diethylamino benzaldehyde in conjunction with a color enhancer reacts with urobilinogen in a strongly acid medium to produce a pink-red color.
Bilirubin: The direct bilirubin and dichlorobenzene diazonium produce fuchsia azo dyes in a strongly acid medium.
Ketone: The acetoacetate and sodium nitroprusside cause a reaction in the alkaline medium, which produces a violet color.
Blood: Hemoglobin acts as a peroxidase. It can cause peroxidase to release neo-ecotypes oxide [O]. [0] oxidizes the indicator and causes the color change.
Protein: The test is based on the protein-error-of-indicators principle. An ion in the specific pH indicator attracted by cation on the protein molecule makes the indicator further ionized, which changes its color.
Nitrite: Nitrite in the urine and aromatic amino sulphanilamide are diazotized to form a diazonium compound. The diazonium compound reacting with tetrahydro benzo (h) quinolin 3-phenol causes the color change.
Leukocytes: Granulocyte leukocytes in urine contain esterase that catalyzes the hydrolysis of the pyrrole amino acid ester to liberate 3-hydroxy-5-pheny pyrrole reacting with diazonium forms a purple color.
Glucose: The glucose oxidized by glucose oxidase catalyzes the formation of glucuronic acid and peroxide hydrogen. Peroxide hydrogen releases neo-ecotypes oxide [0] under the function of peroxidase. [O] oxidizes iodide potassium, which causes the color change.
Specific Gravity: Electrolyte (M+X-) in the form of salt in urine reacts with poly methyl vinyl ether and maleic acid (-COOH), which is a weak acid ionic exchanger. The reaction produces hydrogenous ionogen, which reacts with a pH indicator that causes the color change.
pH: This test is based on a double indicator principle that gives a broad range of colors covering the
2
entire urinary pH range.
Ascorbic Acid: Ascorbic acid, with 1, 2-dihydroxy alkenes, under the alkaline condition, deoxidizes the blue 2, 6-dichloroindophenolate into colorless N- (p-phenol)-2, 6-dichloro-p-amine phenol.
Technological characteristics
Studies were performed with the reference URISTK H Series Reagent Strips for Urinalysis and Urine Analyzer. And substantial equivalence has been demonstrated to the reference method.
Comparison with the predicate:
| Differences and Similarities | ||
|---|---|---|
| Item | New Device | Predicate Device |
| Intended Use | Healgen Series Reagent Strips for | |
| Urinalysis are in vitro diagnostic test | ||
| devices that use reagents for qualitative | ||
| and semi-quantitative urinalysis. The | ||
| strips are for professional use only. | ||
| Healgen Series Reagent Strips for | ||
| Urinalysis are intended for use to detect | ||
| conditions indicating possible diabetes, | ||
| metabolic abnormalities, liver diseases, | ||
| kidney function, and urinary tract | ||
| infections. Test results can be used | ||
| along with other diagnostic information | ||
| to rule out certain disease states and to | ||
| determine if microscopic analysis is | ||
| needed. | This guide instructs the methods, | |
| reaction principles and points for | ||
| attention for the use of URISTK H | ||
| Series of Reagent Strips. URISTK | ||
| H Series of Reagent Strips are | ||
| made for urinalysis both | ||
| qualitative and semi-quantitative, | ||
| which are in vitro reagent for | ||
| diagnostics. The strips are for | ||
| professional use only. The results | ||
| on the strips can be read visually | ||
| and instrumentally. You are | ||
| required to read the User's Guide | ||
| before taking use of the strips. | ||
| Specimen | Fresh urine | The same |
| Methodology | Established clinical chemistry methods | The same |
| Test strip analytes that | ||
| can be read | Urobilinogen, Bilirubin, Ketone, Blood, | |
| Protein, Nitrite, Leukocytes, Glucose, | ||
| Specific Gravity, pH, and Ascorbic Acid | The same | |
| Strip Incubation Time | Immerse the reagent area of the strip in | |
| the urine specimen and take it up | ||
| quickly and immediately. | The same | |
| Detection | Reflectance Photometry | The same |
| PC Port | Standard RS232C | The same |
| Analyzer Operating | ||
| Conditions | 0~40°C:RH |