K Number

Device Name

IMX SELECT CHLAMYDIA

Manufacturer

ABBOTT LABORATORIES

Date Cleared

1996-05-30

(891 days)

Product Code

LJC

Regulation Number

866.3120

Intended Use

IMx SELECT Chlamydia is a Micropaticle Enzyme Immunoassay (MEIA) for the qualitative detection of chlamydial LPS antigen and is indicated for use in testing female endocervical swab specimens, and male urethral swab specimens from symptomatic individuals to identify Chlamvia trachomatis. The IMx SELECT Chamydia Blocking Reagent may be used to verify the chlamydial specificity of the antigen detected.

Device Description

Micropaticle Enzyme Immunoassay (MEIA) for the qualitative detection of chlamydial LPS antigen.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay (MEIA) for antigen detection, with no mention of AI/ML terms, image processing, or complex algorithmic analysis beyond standard assay interpretation.

Therapeutic

No
This device is an immunoassay for detecting chlamydial antigens, which is a diagnostic purpose, not a therapeutic one.

Diagnostic

Yes
This device is a Micropaticle Enzyme Immunoassay (MEIA) for the qualitative detection of chlamydial LPS antigen, intended for use in testing swab specimens to identify Chlamydia trachomatis. The purpose of identifying the presence of a pathogen in a symptomatic individual is to aid in the diagnosis of an infection.

SaMD (Software as a Medical Device)

The device is a Micropaticle Enzyme Immunoassay (MEIA), which is a laboratory-based test involving reagents and physical processes, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "qualitative detection of chlamydial LPS antigen" in "female endocervical swab specimens, and male urethral swab specimens." This involves testing biological samples in vitro (outside the body) to diagnose a condition (Chlamydia trachomatis infection).
Device Description: The description confirms it's a "Micropaticle Enzyme Immunoassay (MEIA)," which is a laboratory technique performed in vitro.
Anatomical Site: The specified anatomical sites are where the biological samples are collected for in vitro testing.

These characteristics clearly align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

IMx SELECT Chlamydia is a Micropaticle Enzyme Immunoassay (MEIA) for the qualitative detection of chlamydial LPS antigen.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Endocervical, Urethral

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A total of 1647 specimens were obtained from patients attending 6 different clinics, including sexually transmitted disease clinics, family planning clinics and OB/GYN clinics. The overall results were summarized by symptomology, prevalence, and site. The performance was measured against culture with discordant resolution by DFA.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The study involved testing 1647 specimens.
Key results are presented in tables detailing performance versus culture with discordant resolution by DFA, summarized by symptomology and by prevalence and site.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Summary by Symptomology (using IMx SELECT Chlamydia Performance versus Culture with Discordant Resolution by DFA):

FEMALE: Total: % Relative Sensitivity (95% CI) 89.9 (148/164) (83.4-94.8), % Relative Specificity (95% CI) 98.6 (982/996) (97.7-99.3), % Positive Predictive Value 91.4 (148/163), % Negative Predictive Value 98.5 (982/997)
FEMALE: Symptomatic: % Relative Sensitivity (95% CI) 89.7 (52/58) (78.8-96.1), % Relative Specificity (95% CI) 99.1 (309/312) (95.0-99.3), % Positive Predictive Value 89.7 (52/58), % Negative Predictive Value 98.1 (305/312)
FEMALE: Asymptomatic: % Relative Sensitivity (95% CI) 89.1 (49/55) (77.8-95.8), % Relative Specificity (95% CI) 98.0 (300/306) (96.1-99.1), % Positive Predictive Value 86.0 (49/57), % Negative Predictive Value 96.6 (380/393)
FEMALE: Other: % Relative Sensitivity (95% CI) 94.1 (48/51) (83.6-98.8), % Relative Specificity (95% CI) 100.0 (286/286) (99.0-100.0), % Positive Predictive Value 100.0 (48/48), % Negative Predictive Value 99.0 (286/289)
MALE: Symptomatic: % Relative Sensitivity (95% CI) 63.5 (61/97) (74.6-90.3), % Relative Specificity (95% CI) 99.0 (356/360) (97.4-99.7), % Positive Predictive Value 65.3 (61/93), % Negative Predictive Value 98.0 (396/402)
GRAND TOTAL: % Relative Sensitivity (95% CI) 84.1 (230/261) (63.6-91.4), % Relative Specificity (95% CI) 98.7 (1366/1383) (98.0-99.2), % Positive Predictive Value 92.7 (230/248), % Negative Predictive Value 97.8 (1366/1396)

Summary by Prevalence and Site (using IMx SELECT Chlamydia Performance versus Culture with Discordant Resolution by DFA):

FEMALE: Total: % Relative Sensitivity (95% CI) 90.9 (149/164) (85.4-94.8), % Relative Specificity (95% CI) 98.6 (962/968) (97.7-99.3), % Prevalence 14.1 (164/1160)
HIGH Prevalence: % Relative Sensitivity (95% CI) 94.4 (102/108) (88.3-97.9), % Relative Specificity (95% CI) 98.7 (461/467) (97.2-99.5), % Prevalence 18.8 (108/575)
MID Prevalence: % Relative Sensitivity (95% CI) 84.3 (43/51) (71.4-93.0), % Relative Specificity (95% CI) 98.0 (388/396) (96.1-99.1), % Prevalence 11.4 (51/447)
LOW Prevalence: % Relative Sensitivity (95% CI) 80.0 (4/5) (26.4-99.5), % Relative Specificity (95% CI) 100.0 (133/133) (97.6-100.0), % Prevalence 3.6 (5/136)
MALE: Total: % Relative Sensitivity (95% CI) 83.5 (81/97) (74.6-90.3), % Relative Specificity (95% CI) 99.0 (386/390) (97.4-99.7), % Prevalence 19.9 (97/467)
GRAND TOTAL: % Relative Sensitivity (95% CI) 86.1 (230/261) (83.6-91.9), % Relative Specificity (95% CI) 98.7 (1368/1386) (98.0-99.2), % Prevalence 16.9 (281/1647)

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.

Not Found

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 866.3120 Chlamydia serological reagents.

(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).

Summary

30 1996

K936054,

Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the 510(k) Premarket Notification for IMx SELECT Chlamydia constitutes data supporting a substantially equivalent determination:

IMx SELECT Chlamydia is compared to isolation of C. trachomatis in tissue culture.

IMx SELECT Chlamydia and isolation of C. trachomatis in cell culture are substantially equivalent in that:

Both are intended for the detection of C. trachomatis infection. 8.
Both are in vitro tests. b.

IMx SELECT Chlamydia and isolation of C. trachomatis in cell culture differ in that:

IMx SELECT Chlamydia measures C. trachomatis antigen and ਕ. therefore detects chlamydia which fail to grow in cell culture.
IMx SELECT Chlamydia can be preformed in less than ninety b. minutes whereas cell culture techniques require a minimum of 48 hours before results are obtained.
IMx SELECT Chlamydia specimens do not require special C. handling and storage procedures to retain viability.

A total of 1647 specimens were obtained from patients attending 6 different clinics, including sexually transmitted disease clinics, family planning clinics and OB/GYN clinics. The overall results, presented by symptomology and by prevalence and site, are shown in the tables below:

	IMx SELECT Chlamydia Performance versus Culture with Discordant Resolution by DFA
Summary by Symptomology

| Population By
Sample Type | Wk;
Culture/
DFA | Pos
Pos
NA | Pos
Neg
Pos | Neg
Neg
Neg | Neg
Pos
NA | Neg
Neg
NA | Total number
of Samples | % Relative
Sensitivity
(95% CI) | % Relative
Specificity
(95% CI) | % Positive
Predictive
Value | % Negative
Predictive
Value |
|------------------------------|------------------------|------------------|-------------------|-------------------|------------------|------------------|-------------------------------|---------------------------------------|---------------------------------------|-----------------------------------|-----------------------------------|
| FEMALE: Total | 134 | 15 | 14 | 15 | 982 | 1160 | 89.9 (148/164)
(83.4-94.8) | 98.6 (982/996)
(97.7-99.3) | 91.4 (148/163) | 98.5 (982/997) | |
| FEMALE: Symptomatic | 46 | 8 | 8 | 8 | 308 | 370 | 89.7 (52/58)
(78.8-96.1) | 99.1 (309/312)
(95.0-99.3) | 89.7 (52/58) | 98.1 (305/312) | |
| FEMALE: Asymptomatic | 44 | 5 | 8 | 8 | 390 | 453 | 89.1 (49/55)
(77.8-95.8) | 98.0 (300/306)
(96.1-99.1) | 86.0 (49/57) | 96.6 (380/393) | |
| FEMALE: Other | 44 | 4 | 0 | 3 | 286 | 337 | 94.1 (48/51)
(83.6-98.8) | 100.0 (286/286)
(99.0-100.0) | 100.0 (48/48) | 99.0 (286/289) | |
| MALE: Symptomatic | 86 | 15 | 4 | 16 | 366 | 407 | 63.5 (61/97)
(74.6-90.3) | 99.0 (356/360)
(97.4-99.7) | 65.3 (61/93) | 98.0 (396/402) | |
| GRAND TOTAL | 200 | 30 | 18 | 31 | 1368 | 1647 | 84.1 (230/261)
(63.6-91.4) | 98.7 (1366/1383)
(98.0-99.2) | 92.7 (230/248) | 97.8 (1366/1396) | |

NA is not applicable. DFA lending real performance

CI is Confidence Intervals

' Reason provided doesn't or no specific information provided
with the request is valid.

: 20 IFLie 28/29 specimena have