(279 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study data for the Healgen Series Reagent Strips and Analyzers for Urinalysis:
Overview:
The submission (K111999) describes the Healgen Series Reagent Strips and Analyzers, in-vitro diagnostic devices for qualitative and semi-quantitative urinalysis of various analytes. The primary goal of the submission appears to be demonstrating substantial equivalence to a predicate device (URISTK H Series Reagent Strips for Urinalysis and Dirui H-50, H-100, or H-500 Urine Analyzer). The information provided largely focuses on the analytical performance of the device rather than a clinical outcome study.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes analytical performance characteristics but does not explicitly state acceptance criteria for a "device meets acceptance criteria" study in the typical sense of a clinical trial with predefined end-points for sensitivity/specificity. Instead, it demonstrates the analytical capabilities and equivalence to a predicate device.
The tables below summarize the reported analytical performance related to:
- Analytical Limits (Cutoff): These are the thresholds at which a positive or negative result is typically determined.
- Reportable Ranges: These define the concentration ranges within which the device can provide meaningful qualitative or semi-quantitative results.
- Analytical Specificity (Interference Study): This identifies substances and their concentrations that do not affect the test results.
Table 1: Analytical Limits (Cutoffs)
| Analyte | Unit | Cutoff |
|---|---|---|
| Urobilinogen | mg/dl | 0.7 |
| Bilirubin | mg/dl | 0.7 |
| Ketone | mg/dl | 3.5 |
| Blood | cells/µL | 6.5 |
| Protein | mg/dl | 7.2 |
| Nitrite | µg/dL | 50 |
| Leukocytes | cells /µL | 10 |
| Glucose | mg/dl | 65 |
| Ascorbic Acid | mg/dl | 6.5 |
| pH | 5.6 | |
| Specific Gravity | 1.003 |
Table 2: Reportable Ranges
| Analyte | Unit | Lab Assay Range | Reportable Range |
|---|---|---|---|
| Urobilinogen | mg/dl | 0.01-18.75 | 0.2-8 |
| Bilirubin | mg/dl | 0-18.8 | 0-6 |
| Ketone | mg/dl | 0.2-350 | 0-160 |
| Blood | cells/μL | 0-350 | 0-200 |
| Protein | mg/dl | 0.3-5000 | 0-2000 |
| Nitrite | mg/dl | 5.0-2000 | Neg-Pos |
| Leukocytes | cells/μL | 0-800 | 0-500 |
| Glucose | mg/dl | 0-5500 | 0-2000 |
| Specific Gravity | 1.000-1.040 | 1.000-1.030 | |
| pH | 0-14.0 | 5.0-8.5 | |
| Ascorbic Acid | mg/dl | 1-230 | 0-100 |
Table 3: Analytical Specificity - Non-Interfering Concentrations of Substances
| Potential Interfering Substance | Concentration Not Affecting Test |
|---|---|
| Albumin | 800 mg/dL |
| Ascorbic Acid | 50 mg/dL |
| Hemoglobin | 50 mg/dL |
| Citric Acid | 50 mg/dL |
| Bilirubin | 3.0 mg/dL |
| Creatine | 8 mg/dL |
| Acetoacetate Acid | 1 mmol/L |
| Ammonium Chloride | 189 mg/dL |
| Calcium Chloride | 50 mg/dL |
| Creatinine | 800 mg/dL |
| Glucose | 2000 mg/dL |
| Glycine | 1000 mg/dL |
| KCL | 550 mg/dL |
| NaCl | 2800 mg/dL |
| Oxalic Acid | 70 mg/dL |
| Sodium Acetate | 1200 mg/dL |
| Sodium Bicarbonate | 1500 mg/dL |
| Sodium Nitrate | 0.26 mg/dL |
| Sodium Nitrite | 0.3 mg/dL |
| Sodium Phosphate | 16 mg/dL |
| Urobilinogen | 3.0 mg/dL |
| Urea | 3000 mg/dL |
| Riboflavin | 100 mg/L |
| Theophylline | 100 mg/L |
| Phenolphthalein | 1200 mg/L |
| pH | 9.0 |
| Specific gravity | 1.030 |
| Glutathione | 200mg/dL |
| Hypochlorite | 10mg/L |
| Chlorine | 1mg/dL |
| Peroxide | 1mg/L |
| Atropine | 300mg/L |
| Fructose | 5000 mg/dL |
| Lactose | 5000 mg/dL |
| Leucocytes | 800 Cell/ μL |
| Ketone | 200 mg/dL |
| Blood | 300 Cell/ μL |
| Mesna | 50mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Precision (repeatability/reproducibility):
- Within-run: 20 replicates for each of 3 urine control levels, using strips from 3 lots.
- Within-day: 3 urine control levels analyzed in duplicate, once a day, for 10 days, using strips from 3 lots.
- Analytical Specificity: 5 test strips from each of 3 lots for each interference test.
- Sample Size for Clinical Comparison Studies: Not explicitly stated with a specific number of clinical specimens. The text only mentions "clinical comparison studies were conducted in 3 sites using the Healgen 11 Reagent Strip for Urinalysis and the predicate devices."
- Data Provenance: Not explicitly stated (e.g., country of origin). The document implies the studies were conducted to support a submission to the US FDA, but does not specify the geographic location of the clinical sites or specimen collection. The study appears to be prospective for the analytical performance evaluations (precision, specificity) as these were performed as part of the validation. The "clinical comparison studies" also imply prospective data collection for comparison purposes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts: The precision study involved "6 technicians" across 3 clinical sites. No specific qualifications (e.g., years of experience, specific certifications) are provided for these technicians, nor are they explicitly stated as "experts establishing ground truth."
- Ground Truth Qualification: For the precision and analytical specificity studies, the ground truth was established by using urine controls (Bio-Rad Level 1 and Level 2) and a 3rd control with analyte concentrations around cutoff, which was created by pooling Bio-Rad controls and spiking with pure analytes. For the clinical comparison study, the "ground truth" was implicitly the result obtained by the predicate device, as the study aimed to show comparability. There is no mention of external expert consensus or a gold standard method separate from the predicate for establishing ground truth for the clinical specimens.
4. Adjudication Method for the Test Set
- No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The analytical studies used technical replication (e.g., 20 replicates, duplicates over 10 days). For the clinical comparison, the comparison was made against the predicate device, suggesting the predicate's results served as the reference for comparability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
- No, an MRMC comparative effectiveness study was not explicitly described in the provided text in the typical sense of measuring human reader improvement with AI assistance.
- The document mentions "visual reading" alongside "instrumental reading" for the Healgen strips and states 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." This indicates a comparison between visual and instrumental readings, and between the new device and the predicate. However, it does not detail a study specifically designed to assess human reader improvement with AI (in this case, the analyzer acting as an 'AI' for reading strips) versus without it.
- The effect size of how much human readers improve with AI vs without AI assistance is not provided or discussed. The focus is on the performance comparability of the device (both visual and instrumental readings) to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a form of standalone performance was implicitly studied for the instrumental reading. The Healgen 500 and 800 Urine Analyzers use "reflectance photometry to quantitate analyte values" and provide "instrumental reading." Precision, analytical limits, and reportable ranges are characteristics of the instrument's performance (the "algorithm") when reading the strips. The "analytical specificity" study also evaluates the instrument's performance in the presence of interfering substances. While not strictly an "AI algorithm" in the modern interpretative sense, the analyzers are automated systems that perform the reading without human interpretation beyond initiating the test and reading the display.
7. The Type of Ground Truth Used
- For analytical performance (precision, reportable ranges, analytical specificity): The ground truth was based on controlled lab-prepared samples using Bio-Rad urinalysis controls and custom-spiked controls with known analyte concentrations.
- For clinical comparison studies: The ground truth was the results obtained from the predicate device (URISTK H Series Reagent Strips for Urinalysis and Dirui H-50, H-100, or H-500 Urine Analyzer).
8. The Sample Size for the Training Set
- The document does not explicitly mention a separate "training set" for an AI or machine learning model. This is consistent with the nature of reflectance photometry-based devices, which typically rely on calibrated physics-based models rather than data-driven machine learning for their primary function of quantifying color changes. The development of the reagents and the instrumental reading parameters would be based on chemical principles and extensive analytical validation rather than a distinct machine learning training set.
9. How the Ground Truth for the Training Set Was Established
- As a distinct "training set" for AI/ML is not described, the concept of establishing ground truth for it is not applicable in the context of this submission. The device's operational parameters and measurement accuracy are established through the analytical performance studies rather than a machine learning training process.
{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 LLC5213 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 forUrinalysis are in vitro diagnostic testdevices that use reagents for qualitativeand semi-quantitative urinalysis. Thestrips are for professional use only.Healgen Series Reagent Strips forUrinalysis are intended for use to detectconditions indicating possible diabetes,metabolic abnormalities, liver diseases,kidney function, and urinary tractinfections. Test results can be usedalong with other diagnostic informationto rule out certain disease states and todetermine if microscopic analysis isneeded. | This guide instructs the methods,reaction principles and points forattention for the use of URISTK HSeries of Reagent Strips. URISTKH Series of Reagent Strips aremade for urinalysis bothqualitative and semi-quantitative,which are in vitro reagent fordiagnostics. The strips are forprofessional use only. The resultson the strips can be read visuallyand instrumentally. You arerequired to read the User's Guidebefore taking use of the strips. |
| Specimen | Fresh urine | The same |
| Methodology | Established clinical chemistry methods | The same |
| Test strip analytes thatcan 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 inthe urine specimen and take it upquickly and immediately. | The same |
| Detection | Reflectance Photometry | The same |
| PC Port | Standard RS232C | The same |
| Analyzer OperatingConditions | 0~40°C:RH < 85% | The same |
| Wavelength | 420nm, 525nm, 560nm, 610nm, 660nm,950nm | The same |
| Calibration | Done with a cilibration strip | The same |
| Strip Operating | Semi-automatic | The same |
| Available Languages onscreen | English | The same |
| Power Source | AC 220V(±15%),50~60Hz | The same |
| Line Leakage Current | <0.5 milliamperes in normal condition;<3.5 milliamperes in single faultcondition | The same |
| Memory | 1000 test results | The same |
| Throughput | Healgen 500: 120 test/hourHealgen 800: 500 test/hour | Dirui-50: 60 test/hourDirui-100: 120 test/hourDirui-500: 500 test/hour |
| Dimensions | 355mm×300mm×145mm | 324mm×327mm×185mm |
| Weight | 4kg. | About 5kg |
| Display Dimensions | Healgen 500 240mm64mm Healgen 800 240mm128mm | Dirui-50: 240mm64mm Dirui-100: 240mm64mm Dirui-500240mm*128mm |
{3}------------------------------------------------
Performance
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:
| Analyte | Unit | Cutoff |
|---|---|---|
| Urobilinogen | mg/dl | 0.7 |
| Bilirubin | mg/dl | 0.7 |
| Ketone | mg/dl | 3.5 |
| Blood | cells/µL | 6.5 |
| Protein | mg/dl | 7.2 |
| Nitrite | µg/dL | 50 |
| Leukocytes | cells /µL | 10 |
| Glucose | mg/dl | 65 |
| Ascorbic Acid | mg/dl | 6.5 |
| 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.
{4}------------------------------------------------
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 following table:
| Analyte | Unit | Lab Assay Range | Reportable Range |
|---|---|---|---|
| Urobilinogen | mg/dl | 0.01-18.75 | 0.2-8 |
| Bilirubin | mg/dl | 0-18.8 | 0-6 |
| Ketone | mg/dl | 0.2-350 | 0-160 |
| Blood | cells/μL | 0-350 | 0-200 |
| Protein | mg/dl | 0.3-5000 | 0-2000 |
| Nitrite | mg/dl | 5.0-2000 | Neg-Pos |
| Leukocytes | cells/μL | 0-800 | 0-500 |
| Glucose | mg/dl | 0-5500 | 0-2000 |
| Specific Gravity | 1.000-1.040 | 1.000-1.030 | |
| pH | 0-14.0 | 5.0-8.5 | |
| Ascorbic Acid | mg/dl | 1-230 | 0-100 |
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 as below:
| Potential Interfering Substance | Concentration Not Affecting Test |
|---|---|
| Albumin | 800 mg/dL |
| Ascorbic Acid | 50 mg/dL |
| Hemoglobin | 50 mg/dL |
| Citric Acid | 50 mg/dL |
| Bilirubin | 3.0 mg/dL |
| Creatine | 8 mg/dL |
| Acetoacetate Acid | 1 mmol/L |
| Ammonium Chloride | 189 mg/dL |
| Calcium Chloride | 50 mg/dL |
| Creatinine | 800 mg/dL |
| Glucose | 2000 mg/dL |
| Glycine | 1000 mg/dL |
| KCL | 550 mg/dL |
| NaCl | 2800 mg/dL |
| Oxalic Acid | 70 mg/dL |
| Sodium Acetate | 1200 mg/dL |
| Sodium Bicarbonate | 1500 mg/dL |
| Sodium Nitrate | 0.26 mg/dL |
| Sodium Nitrite | 0.3 mg/dL |
{5}------------------------------------------------
| Sodium Phosphate | 16 mg/dL |
|---|---|
| Urobilinogen | 3.0 mg/dL |
| Urea | 3000 mg/dL |
| Riboflavin | 100 mg/L |
| Theophylline | 100 mg/L |
| Phenolphthalein | 1200 mg/L |
| pH | 9.0 |
| Specific gravity | 1.030 |
| Glutathione | 200mg/dL |
| Hypochlorite | 10mg/L |
| Chlorine | 1mg/dL |
| Peroxide | 1mg/L |
| Atropine | 300mg/L |
| Fructose | 5000 mg/dL |
| Lactose | 5000 mg/dL |
| Leucocytes | 800 Cell/ μL |
| Ketone | 200 mg/dL |
| Blood | 300 Cell/ μL |
| Mesna | 50mg/dL |
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.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is composed of two parts: a circular text element and a central graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The central graphic is a stylized depiction of an eagle or bird-like figure with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 1 7 2012
Healgen Scientific, LLC c/o Yongquan Wang Quality Manager 5213 Maple Street Bellaire, TX 77401
K111999 Re:
KT11799
Trade Name: Healgen Series Reagent Strips and Analyzers for Urinalysis Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Regulatory Class. Class II
Product Code: JIO, JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN,JMA, JRE, KQO Dated: April 6, 2012 . Received: April 9, 2012
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the We have feviewed your Socion 310(s) pived the device is substantially equivalent (for device for use stated in the enclosure) to legally marketed predicate devices the indications for use bated in the interest prior to May 28, 1976, the enactment date of the marketed in melstale commerce prior to they __________________________________________________________________________________________________________________________________ Medical Device Amendments, of to Covices mand Cosmetic Act (Act) that do not require with the provisions of the Pocolar Posts, 2008, 1000 may, therefore, market the approval of a premarker approval approvisions of the Act. The general controls device, subject to the general controls pros for annual registration, listing of devices, provisions of the Act merace requiring, 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 (CFF (PMA), if may be subject to such additional controllar contractions (CFR), Parts affecting your device can of round in Title E2, 2011 and mouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does Please be advised that FDA s issualice of a subscriptions administered by other not mean that FDA has made a determinated and regulations administered by other requirements of the Act of ally I county with all the Act's requirements, including, but not
Federal agencies. You must comply with all the Act's requirements, including (21 Federal agencies. You must compry with and 007); labeling (21 CFR Parts 801 and limited to: registration and instillig (2) CFR Parcosy carees glated adverse events) (21 809); medical device reporting (teporting of meetice requirements as set forth in the quality
CFR 803); and good manufacturing practice requirements as set forth in the quali systems (QS) regulation (21 CFR Part 820).
{7}------------------------------------------------
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dento speeding and river Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 productions the regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Once of but remestions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
You may obtain other general information on your responsibilities under the Act from the I ou may of and Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.html
Sincerely yours,
signature
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K111999
Healgen Series Reagent Strips for Urinalysis Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
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."
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature of Offer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 111999
Page 1 of 1
§ 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.