COMBI-SCREEN, MODELS 10SL AND 11SL

K023885 · Analyticon Biotechnologies AG · JIL · Oct 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023885
• Device Name: COMBI-SCREEN, MODELS 10SL AND 11SL
• Applicant: Analyticon Biotechnologies AG
• Product Code: JIL · Clinical Chemistry
• Decision Date: Oct 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Indications for Use

The urine test strips may be used for rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH, Specific Gravity and Leukocytes in urine for the model 10SL, plus Ascorbic acid in urine for the Model 11SL.

Device Story

Combi-Screen Urine Test Strips (Models 10SL and 11SL) are diagnostic strips for semi-quantitative or qualitative chemical urine analysis. User dips strip into urine sample; colorimetric reaction occurs on reagent pads; user compares resulting colors against a provided color chart after 60 seconds. Device provides rapid screening for carbohydrate metabolism disorders (diabetes), kidney/urinary tract infections, and liver/haemolytic disorders. Used in clinical settings or point-of-care; operated by healthcare professionals. Output allows clinicians to assess patient's chemical urine status, aiding in early detection of disease symptoms.

Clinical Evidence

Clinical study conducted at three medical centers comparing Combi-Screen to Chemstrip 10 using fresh, uncentrifuged urine samples (N=128, 102, 185). Primary endpoints included sensitivity, specificity, predictive values, and efficiency. Results showed high concordance; blood sensitivity ranged 76.5%–93.2% and specificity 97.3%–100%; glucose sensitivity ranged 83.3%–100% and specificity 97.4%–100%.

Technological Characteristics

Urine dipstick with multiple reagent pads. Glucose detection via glucose oxidase/peroxidase chromogen; blood detection via pseudoperoxidative activity of hemoglobin/myoglobin. Visual readout against color chart. No electronic components, connectivity, or software.

Indications for Use

Indicated for rapid qualitative determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH, Specific Gravity, Leukocytes, and Ascorbic acid (Model 11SL only) in human urine.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Predicate Devices

• Medi-Test Combo 11 Macherey-Nagel-Duren (K991927)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K023885

B. Analyte:
Urinary Glucose
Urinary Occult blood

C. Type of Test:
Urinary Dipstick/Qualitative

D. Applicant:
ANALYTICON BIOTECHNOLOGIES AG

E. Proprietary and Established Names:
COMBI-SCREEN, MODELS 10SL AND 11SL

F. Regulatory Information:

1. Regulation section:
21 CFR §862.1340 - Urinary glucose (nonquantitative) test system.
21 CFR §864.6550 - Occult blood test.

Class I exempt:
21 CFR §862.1785 - Urinary urobilinogen (nonquantitative) test system.
21 CFR §862.1550 - Urinary pH (nonquantitative) test system.
21 CFR §862.1435 - Ketones (nonquantitative) test system.
21 CFR §862.1645 - Urinary protein or albumin (nonquantitative) test system
21 CFR §862.1115 - Urinary bilirubin and its conjugates (nonquantitative) test system.
21 CFR §862.1095 - Ascorbic acid test system.
21 CFR §862.1510 - Nitrite (nonquantitative) test system.
25 CFR §864.9320 - Copper sulfate solution for specific gravity determinations.
21 CFR §864.7675 - Leukocyte peroxidase test.

2. Classification:
Class 2

3. Product Code:
JIL, JIP

4. Panel:
Chemistry (75), Hematology (81)

G. Intended Use:

1. Indication(s) for use:
The urine test strips may be used for rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH, Specific Gravity and Leukocytes in urine for the model 10SL, plus Ascorbic acid in urine for the Model 11SL.

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2. Special condition for use statement(s):

3. Special instrument Requirements: Not Applicable

H. Device Description:
The COMBI-SCREEN, MODELS 10SL AND 11SL are urine dipsticks for the determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH, Specific Gravity and Leukocytes in urine for the model 10SL, plus Ascorbic acid in urine for the Model 11SL. These devices are class I exempt with the exception of urinary glucose and blood.

I. Substantial Equivalence Information:

1. Predicate device name(s): Medi-Test Combo 11 Macherey-Nagel-Duren
2. Predicate K number(s): K991927
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Indication | The urine test strips may be used for determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH, Specific Gravity Leukocytes and Ascorbic acid in urine for the model 10SL. urine for the Model 11SL. | Same |
| Method | Urine Dipstick check against color chart | Same |
| Timing | 60 seconds | Same |

J. Standard/Guidance Document Referenced (if applicable):
NCCLS EP 12-P User Protocol for Evaluation of Qualitative Test Performance

K. Test Principle:
The measurement of glucose is based on an enzymatic reaction with glucose oxidase/ peroxidase chromogen. Blood is detected based on the pseudoperoxidative activity of hemoglobin and myoglobin, which catalyze the oxidation of an indicator by an organic hydroperoxide and chromogen producing a green color.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Qualitative Method-Reproducibility Experiment for Analyte Concentration Near the Cutoff Method Urine samples were prepared at the cutoff concentration and with

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concentrations 20% above and 20% below the cutoff concentration. 20 replicate tests were carried out with Combi-Screen.

The experiments were performed according "User Protocol for Evaluation of Qualitative Test Performance", EP12-A, Vol. 22, p. 5-6

Test Strips: Combi-Screen 10 SL three lots: 1483; 1399 and 1458

Glucose Combi-Screen, Analyticon

average value

| 20% below | Cut off: 40 mg/dl | 20% above |
| --- | --- | --- |
| 3 x pos. = 5,0 % | 2 x norm = 3,3 % | 60 x pos. = 100% |
| 57 x norm = 95,0% | 58 x pos. =96,7% | |

result: cut off: 40 mg/dl

Blood (lysed and intact) Combi-Screen, Analyticon

| concentration | cut off concentration | concentration |
| --- | --- | --- |
| 20% below | 8 Ery/μl | 20% above |
| 6,5 Ery/μl | | 10 Ery/μl |
| 15 x positive = 25,0 % | 60 x positive = 100% | 60 x positive =100% |
| 45 x negative = 75,0 % | | |

result: cut off (lysed Ery) = ca. (approximately) 5-10 Ery/μl

| 17 x positive = 28,3 % | 4 x negative = 6,7% | 60 x positive =100% |
| --- | --- | --- |
| 43 x negative = 71,7% | 56 x positive = 93,3% | |

result: cut off (intact Ery) = ca. (approximately) 5-10 Ery/μl

b. Linearity/assay reportable range:
Qualitative
Glucose range: negative to 1000 mg/dl
Blood range: negative to 300 Ery/μl

c. Traceability (controls, calibrators, or method):
Not Applicable

d. Detection limit:
Glucose:cut off: 40 mg/dl
Blood: cut off (lysed Ery) = ca. 5-10 Ery/μl
Blood: cut off (intact Ery) = ca. 5-10 Ery/μl

e. Analytical specificity:
Not Applicable

f. Assay cut-off:
Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:
The tests were carried out with urine spiked with definite amount of blood or glucose. The evaluation was carried out by comparison of the reaction color of the test strips with the color chart of the label of the relevant test strips meaning:

number: exact value of concentration: color of reaction corresponds to color chart

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the color of reaction is weaker than color chart; but the color can be assigned to color field
> the color of reaction is stronger than color chart; but the color can be assign to color field
- line means: concentration was not tested; there is not color field on the label

In-house Study: visual measurement: Urinary Glucose Testing of Urine Test Strips Combi-Screen on comparison of commercial Urine Test strips Chemstrip 10 (Roche) Glucose spiked urine with glucose concentration

| Test Strip | normal | 50 mg/dl 100 mg/dl 250 mg/dl 300 mg/dl 500 mg/dl 1000 mg/dl | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | observed concentration, | | | (average of 5 measurements) | | |
| Analyticcon | norm | 50 | 100 | 250 | -- | 500 | 1000 mg/dl |
| 10SL 1458 | | | | | | | |
| Analyticcon | norm | 50 | >100 | 250 | -- | 500 | 1000 mg/dl |
| 10SL 1448 | | | | | | | |
| Analyticcon | norm | 50 | 100 | 250 | -- | 500 | 1000 mg/dl |
| 10SL 1399 | | | | | | | |
| Analyticcon | norm | >50 | 100 | 250 | -- | 500 | 1000 mg/dl |
| 10SL 1316 | | | | | | | |
| Roche | norm | >50 | 100 | -- | 300 | -- | 1000 mg/dl |
| Chemstrip 10 | | | | | | | |
| 28823742 | | | | | | | |

Blood, lysed Ery spiked urine with blood concentration

| Test Strips | negative | 10 Ery/μl | 50 Ery/μl | 250 Ery/μl | 300 Ery/μl |
| --- | --- | --- | --- | --- | --- |
| | observed concentration | | (average of 5 measurements) | | |
| Analyticcon | negative | >10 | >50 | -- | 300 |
| 10 SL 1458 | | | | | |
| Analyticcon | negative | >10 | >50 | -- | 300 |
| 10 SL 1448 | | | | | |
| Analyticcon | negative | 10 | 50 | -- | 300 |
| 10 SL 1399 | | | | | |
| Analyticcon | negative | 10 | 50 | -- | <300 |
| 10 SL 1316 | | | | | |
| Roche | negative | >10 | 50 | 250 | -- |
| Chemstrip 10, 28823742 | | | | | |

Blood, intact Ery spiked urine with blood concentration

| Test Strips | negative | 10 Ery/μl | 50 Ery/μl | 250 Ery/μl | 300 Ery/μl |
| --- | --- | --- | --- | --- | --- |
| | observed concentration, (average of 5 measurements) | | | | |
| Analyticcon | negative | 10 | >50 | -- | 300 |
| 10 SL 1458 | | | | | |
| Analyticcon | negative | <10 | >50 | -- | 300 |
| 10 SL 1448 | | | | | |
| Analyticcon | negative | <10 | <50 | -- | 300 |
| 10 SL 1399 | | | | | |
| Analyticcon | negative | 5-10 | <50 | -- | <300 |
| 10 SL 1316 | | | | | |
| Roche | negative | <10 | <50 | 250 | -- |
| Chemstrip 10, 28823742 | | | | | |

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b. Matrix comparison:
Not Applicable

3. Clinical studies:
Urine Test Strips Combi-Screen (Analytic Brotechnologies AG) were tested on comparison to the commercial available test strips Chemstrip 10-Test (Company Roche) by visual measurement at fresh urine samples of patients at three medical centers. The parameter glucose and blood were tested

Reagent areas on the strips were compared with the corresponding color chart on the container 60 seconds after immersion. Colors falling between two color blocks were read as lower of the two values according to the reading procedure of Roche

Urine samples: fresh, uncentrifuged urine, free of detergent, not spiked;

The data analysis of clinical testing were carried out according "User protocol for Evaluation of Qualitative Test Performance", EP 12-P, Section 9 Data Analysis. Data for sensitivity, specificity, predictive value, efficiency of the test were calculated, Table Data Analysis shows the results

Summarized Results of Clinical Testing of the Urine Test Strips Combi-Screen (Analytic) on comparison to Chemstrip 10 (Roche)

| | | Günzburg | | Lengerich | | Potsdam | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | | Blood | Glucose | Blood | Glucose | Blood | Glucose |
| N total | | 128 | 128 | 102 | 102 | 185 | 182 |
| A true positive | | 39 | 4 | 36 | 5 | 68 | 22 |
| B false positive | | 2 | 0 | 0 | 0 | 3 | 1 |
| C false negative | | 12 | 0 | 11 | 1 | 5 | 0 |
| D true negative | | 75 | 124 | 55 | 96 | 109 | 159 |
| Specificity | 100% D/B+D | a) | 97,40 | 100 | 100 | 100 | 97,30 |
| Sensitivity | 100% A/A+C | b) | 76.47 | 100 | 76,60 | 83,33 | 93,20 |
| Prevalence | 100% A+C/N | c) | 39,84 | 3,13 | 46,08 | 5,88 | 39,46 |
| PVP | 100% A/A+B | d) | 95,12 | 100 | 100 | 100 | 95,77 |
| PVN | 100% D/C+D | e) | 86,21 | 100 | 83,33 | 98,97 | 95,61 |
| Efficiency | 100% A+D/N | f) | 89,06 | 100 | 89,22 | 99,02 | 95,68 |

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Literature

M. Conclusion:
The information and data provided by ANALYTICON BIOTECHNOLOGIES AG supports a Substantial Equivalence (SE) determination to other METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) regulated under 21 CFR §862.1340 - Urinary glucose (nonquantitative) test system., and to other BLOOD, OCCULT, ENZYMATIC METHOD, IN URINE regulated under 21 CFR §864.6550-Occult blood test.