← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K041696

# RAPID READER (K041696)

_American Bio Medica Corp. · DKZ · Jul 12, 2005 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K041696

## Device Facts

- **Applicant:** American Bio Medica Corp.
- **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md)
- **Decision Date:** Jul 12, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Rapid Reader System is designed to read , capture, document and archive ABMC's Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC test"). The Rapid Reader is used to obtain qualitative results (equivalent to manual read test results) and is intended for professional and point of care use only. It is not intended for over the counter sale to non-professionals. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gaschromatography/mass spectrometry (GC/MS).

## Device Story

Rapid Reader is a densitometer/scanner for professional use; analyzes ABMC drugs of abuse screening immunoassays (Rapid Drug Screen, Rapid One, Rapid TEC). Device utilizes a digital camera to capture images of test cassettes inserted into a holder; software algorithm analyzes images to determine qualitative results. Output displayed as POSITIVE, NEGATIVE, or INVALID; provides printout of results. Replaces manual visual interpretation of test lines; provides preliminary screening results to determine need for confirmatory GC/MS testing. Used in clinical/professional settings to document and archive test results.

## Clinical Evidence

Bench testing only. Comparison study performed using 14 drugs of abuse with ABMC Rapid One assay. Study compared Rapid Reader interpretation against manual interpretation by three untrained professionals. Results showed 100% agreement for negative specimens and 100% agreement for positive specimens (above cutoff).

## Technological Characteristics

Reflected density measurement system using a digital CCD camera. Software-based algorithm (Master Function) interprets optical density of biochemical reactions. Standalone instrument; connects to computer for display. No specific material standards or connectivity protocols (e.g., DICOM) listed. Complies with ISO 9001:2000, 98/79/EC, and electromagnetic compatibility standards.

## Regulatory Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

## Predicate Devices

- Triage Meter (k973547)

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k041696

B. Purpose for Submission:
New Device

C. Manufacturer and Instrument Name:
American Bio Medica Corporation

D. Type of Test or Tests Performed:
The Rapid Reader System is a reader designed to capture, document and archive ABMC Drug of Abuse qualitative test results using Rapid Drug Screen, Rapid One, and Rapid TEC Multiple Dip Stick.

E. System Descriptions:

1. Devise Description:
The Rapid Reader System utilizes a digital camera and software algorithm to detect and read the presence and/or absence of the test and control lines of American Bio Medica Corporation’s urine drugs of abuse screening assays. These assays include Rapid Drug Screen, Rapid One, or Rapid TEC drug of abuse test for the simultaneous detection of up to 10 drugs of abuse in human urine.

2. Principles of Operation:
Reflected density measurement

3. Modes of Operation:
The Rapid Reader is an instrument that evaluates the reflection or optical density, of a biochemical reaction compared to the environmental background of the measurement sample. Measurement values of the Rapid Reader are correlated linearly to the reflected density measurements of the control function.

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4. Specimen Identification:

Urine

5. Specimen Sampling and Handling:

Fresh urine samples should be used. Urine samples do not require any special handling or pretreatment. Urine samples should be tested as soon as possible after collection. However, urine specimens may be refrigerated at 2° to 8°C for 2 days or frozen at -20°C for longer periods.

6. Calibration:

The assessment of qualitative measurements is achieved by creating an algorithm, or Master Function, in the Reader's software. This Master Function is then used to interpret the image received from the CCD camera's scans of the drug test. The Reader's software then outputs to the computer screen a test result reported as "POSITIVE", "NEGATIVE", or "INVALID".

7. Quality Control:

The control card is provided by ABMC to evaluate the performance of the Rapid Reader. Frequency of measurements of the control card should correspond to local practices to quality control the system.

8. Software:

FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:

☑ Yes ☐ X or No

F. Regulatory Information:

1. Regulation section:

21 CFR 862.2560, Fluorometer for clinical use; 21 CFR 862.3100, Amphetamine Test System; 21 CFR 862.3150, Barbiturate Test System; 21 CFR 862.3170, Benzodiazepine Test System; 21 CFR 862.3870, Cannabinoids Test System; 21 CFR 862.3250, Cocaine and Cocaine Metabolites Test System; 21 CFR 862.3610, Methamphetamine Test System; 21 CFR 862.3620, Methadone Test System; 21 CFR 862.3640, Morphine Test System

2. Classification:

Class I; Class II

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3. Product code:
KHO; DKZ; DIS; JXM; LDJ; DIO; DJC; DJR; DPK; DJG; LCM; JXN; LFG

4. Panel:
Clinical Chemistry (75); Clinical Toxicology (91)

G. Intended Use:

1. Indication(s) for Use:
The Rapid Reader System is designed to automatically read, capture, document, and archive ABMC’s Rapid Drug Screen, Rapid One, and Rapid TEC screening immunoassays (“ABMC tests”). The Rapid Reader is used to obtain qualitative results and is intended for professional and point of care use only. It is not intended for over the counter sale to non-professionals. The Rapid Reader, combined with ABMC tests, is simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS) or HPLC.

After having performed the ABMC tests (according to instructions for use of each ABMC tests) the ABMC test is inserted into the device holder of the Rapid Reader. The Rapid Reader scan the device, and the results are displayed.

The performance characteristics of the device have not been determined for use as point of care. This statement of intended use will be included in the operation manual.

2. Special Conditions for Use Statement(s):
None

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:
Triage Meter, k973547

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2. Comparison with Predicate Device:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | Determines qualitative positive or negative result from drug of abuse immunoassay screens. | Determines qualitative positive or negative result from drug of abuse immunoassay screens.  |
|  Measurement method | Scan the sample | Scan the sample  |
|  Output | Outputs “positive” or “Negative” result on paper printout | Outputs “positive” or “Negative” result on paper printout  |

I. Special Control/Guidance Document Referenced (if applicable):

DIN ES ISO 9001:2000 Quality Management Systems

98/79/EC Directive on in vitro diagnostic medical device

89/336/EWG Electromagnetic compatibility

73/23/EWG Low voltage guideline

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

The Rapid Reader interpretation of results was compared to manual interpretation (human eye interpretation) of ABMC’s Rapid One devices. Certified negative and positive controls for each of the 14 drugs of abuse were tested using ABMC’s Rapid One assay by three untrained professionals for each of 14 drugs. The results were then interpreted both manually and using two ARMC Rapid Readers by each of the operators. The results are summarized as following:

Amphetamine

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 3 | 45  |
|  Manual |  |   |
|  + | 51 | 9  |
|  - | 0 | 36  |

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Agreement of Rapid Reader with reference method – 97%

Barbiturates

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 0 | 48  |
|  Manual |  |   |
|  + | 48 | 9  |
|  - | 0 | 39  |

Agreement of Rapid Reader with reference method – 100%

Benzodiazepines

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 15 | 33  |
|  Manual |  |   |
|  + | 63 | 8  |
|  - | 0 | 25  |

Agreement of Rapid Reader with reference method – 84%

Cocaine

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 1 | 47  |
|  Manual |  |   |
|  + | 49 | 14  |
|  - | 0 | 33  |

Agreement of Rapid Reader with reference method – 99%

Methadone

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 12 | 36  |
|  Manual |  |   |
|  + | 60 | 6  |
|  - | 0 | 30  |

Agreement of Rapid Reader with reference method – 87%

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MDMA

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 8 | 40  |
|  Manual |  |   |
|  + | 56 | 7  |
|  - | 0 | 33  |

Agreement of Rapid Reader with reference method – 92%

Methamphetamines

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 2 | 46  |
|  Manual |  |   |
|  + | 50 | 11  |
|  - | 0 | 35  |

Agreement of Rapid Reader with reference method – 98%

Opiates 300

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 14 | 34  |
|  Manual |  |   |
|  + | 62 | 5  |
|  - | 0 | 29  |

Agreement of Rapid Reader with reference method – 85%

Opiates 2000

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 9 | 39  |
|  Manual |  |   |
|  + | 57 | 4  |
|  - | 0 | 35  |

Agreement of Rapid Reader with reference method – 91%

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Oxycodone

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 4 | 44  |
|  Manual |  |   |
|  + | 52 | 6  |
|  - | 0 | 38  |

Agreement of Rapid Reader with reference method – 96%

Phencyclidine

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 3 | 45  |
|  Manual |  |   |
|  + | 51 | 6  |
|  - | 0 | 39  |

Agreement of Rapid Reader with reference method – 97%

Propoxyphene

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 6 | 42  |
|  Manual |  |   |
|  + | 54 | 6  |
|  - | 0 | 36  |

Agreement of Rapid Reader with reference method – 94%

THC

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 0 | 48  |
|  Manual |  |   |
|  + | 48 | 0  |
|  - | 0 | 48  |

Agreement of Rapid Reader with reference method – 100%

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Tricyclic Antidepressants (TCA)

|   | Rapid Reader  |   |
| --- | --- | --- |
|  GC/MS | + | -  |
|  + | 48 | 0  |
|  - | 7 | 41  |
|  Manual |  |   |
|  + | 55 | 8  |
|  - | 0 | 33  |

Agreement of Rapid Reader with reference method – 93%

|  Concentration | Rapid Reader % Agreement | Manual Read % Agreement  |
| --- | --- | --- |
|  Drug Free | 100% | 100%  |
|  50% of Cutoff | 75% | 44%  |
|  125% of Cutoff | 100% | 100%  |
|  150% of Cutoff | 100% | 100%  |

Overall agreement of the Rapid Reader with reference method – 94%

b. Precision/Reproducibility:

The tests described in accuracy section above were the control samples that were tested in triplicate and read by three different operators on two readers over a period of time. The results listed above are adequate to support the precision performance of the Rapid Reader.

c. Linearity:

Not applicable

d. Carryover:

Not applicable

e. Interfering Substances:

The interfering substances information in the previous 510(k) submissions from the same applicant for Rapid Drug Screen and Rapid One, Rapid Drug Rapid One Propoxyphene, Rapid One ECATASY, Rapid One Methadone, Rapid One OXY, and Rap Tec Multiple Dip Stick are applicable for this submission.

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2. Other Supportive Instrument Performance Data Not Covered Above:
Measurement of Reflective Density using American Bio Medica Corporation Rapid Reader

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K041696](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K041696)

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